Clinical trial NCT04500158
Conditions: Pain, Procedural
Sponsor: Virginia Commonwealth University
Start date: 2020-11-03; Completion date: 2024-02-28
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare patient responses during and after surgery when local anesthetic is used for dental treatment under general anesthesia (GA) and when it is not used.

Detailed description:
Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental office. This is usually accomplished by administering a shot of numbing medicine (local anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for care in the dental office however despite its standardized use in dental clinics use of local anesthetic is not standardized for use in dental cases under GA. In the literature there is some evidence suggesting that it has some marginal benefit for pain control short term post operatively and control of vital signs during surgery. Some evidence also suggests that due to its use there can be increase in post-operative lip chewing and cheek biting due to the numb sensation. Additionally, it has been seen that due to the numb sensation that children can be more irritable during when waking up after surgery.

The study section will have 60 participants of which one half will receive local anesthesia for restorative dental care under GA and the other half will receive conventional no anesthesia for restorative dental treatment under GA, based on random assignment (like the flip of a coin). There is an equal chance of being assigned to either group prior to the consented treatment. Before the surgery, a nurse will access the child's overall pain and comfort. The study team (faculty, anesthesiologist, and resident) will record the blood pressure, heart rate, and breathing duration throughout the procedure. After the child has completed the surgery a nurse will again access the child's overall pain and comfort. Lastly, parents will be contacted that evening of surgery by a member of the study team to check up on the child and will be asked some questions to access the child's comfort at home.

Arms: arm 1: Participants will receive local anesthesia in addition to the standard care general anesthesia arm 2: Participants will receive standard care general anesthesia
Interventions: intervention 1: Lidocaine
Intervention descriptions: intervention 1: 2% Lidocaine with 1:100,000 epi

Protocol documents:
Prot_SAP_001.pdf: 
Print
 
Close
HM20018316
View: SF - Study Identification
Date: Monday, August 19, 2024 12:47:15 PM
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Study Identification
1. * Select the Principal Investigator:
Elizabeth Bortell
2. * Study Title:
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative
Comfort
3. * Is this a student or trainee project in which activities will be carried out by that individual under your
supervision (for example, dissertation or degree-required projects):
  Yes
No
If this project involves more than one student / trainee investigator, identify the primary contact here and list all student
/ trainee investigators in the Personnel section. Also ensure all are listed as protocol editors if they need to be copied
on IRB correspondence and have authority to make edits.
4. * Student/Trainee Investigator:
Elizabeth Kleefisch
5. * Please select the primary department or center that this study is being conducted under:
Pediatric Dentistry
6. Select the VCU IRB numbers assigned to studies that are:
      1. Associated with this study
      2. Research registries this study will utilize
      3. Previously submitted versions of this study (closed, withdrawn, auto-withdrawn studies)
ID
Title
PI
There are no items to display
7. Select all individuals who are permitted to edit the IRB protocol and should be copied on communications
(study staff will be entered later).  These individuals will be referred to as protocol editors:
Last Name
First Name
E-Mail
Phone
Mobile
Carrico
Caroline
ckcarrico@vcu.edu
8048288328
 
Kleefisch
Elizabeth
kleefisches@vcu.edu
 
 
8. * Select one of the following that applies to the project (selection will branch to new pages):
Note: VCU IRB offers guidance for many types of studies, including secondary data analysis studies, internet
research, registries, EFIC, HUD, and Emergency Use protocols.
See https://research.vcu.edu/human_research/guidance.htm 
Research Project or Clinical Investigation [*most exempt, expedited, and full board research studies]
Exception from Informed Consent (EFIC) for Planned Emergency Research
Humanitarian Use of Device for Treatment or Diagnosis
Humanitarian Use of Device for Clinical Investigation


Emergency Use of Investigational Drug, Biologic or Device
Treatment Use (Expanded Access to Investigational Product for Treatment Use)
Center or Institute Administrative Grant Review
Request for Not Human Subject Research Determination (i.e. request a letter confirming that IRB review is not
required)


HM20018316
View: SF2 - Federal Regulations
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Federal Regulations
1. * Is this a FDA regulated study?
FDA regulated research includes all clinical investigations involving a test article and a human subject(s) that
has been submitted for approval to the FDA or may be submitted in the future. 
Check Yes if
•    the study involves an IND/IDE, abbreviated IDE, IND/IDE exemption, HUD, expanded access, or is otherwise
subject to 21 CFR 56, 
•    the study involves a test article being administered or dispensed to subjects NOT according to a clinicians’
medical judgment but rather, per the study protocol, OR
•    the study does not involve a test article but intends to provide safety or efficacy data to the FDA.
 
  Yes
No
2. * Indicate the FDA regulated product(s) this study involves:

Drug

Medical Device

Biologic

Dietary Supplement

Food/Food Additive

Color Additive

Electronic Products for Human Use (radiation producing)

Tobacco Product

Other
3. * Is this study supported by the Department of Defense (DoD):
  Yes
No
4. * Check if any of the following funding sources apply to this research (including Direct and/or Indirect
funding):

Department of Education

Department of Justice

Environmental Protection Agency

None of the above


HM20018316
View: SF2 - IRB Panel Setup
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
IRB Panel Setup
1. * To which IRB is this study being submitted for review?
VCU IRB
WCG IRB
NCI Central IRB
Advarra IRB
Other IRB
2. * Is this study transitioning to review by another IRB?
Yes - transitioning from VCU IRB to an external IRB (WCG, CIRB, Other)
Yes - transitioning from an external IRB (WCG, CIRB, Other) to VCU IRB
No or not applicable


HM20018316
View: SF2 - Review Setup
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Review Setup
1. * Select which study type best describes the majority of the study. Your response will help determine which
IRB panel should review this.
Bio-Medical Research
Social/Behavioral/Education (SBE) Research
2. * Which option(s) best describe the way(s) this study’s procedures will be conducted? (Select all that apply.)
This information may be used by the IRB in triaging studies during an emergency.

In-person interactions / interventions with participants

Remote interactions / interventions with participants

Secondary data/specimen analyses with or without contact with study participants
3. * Would it be possible to convert in-person activities in your study to remote if there is an approved
contingency protocol? 
No, not possible to convert to remote activities
 
4. * Does this study involve greater than minimal risk:
  Yes No
5. * Review type requested: (subject to IRB approval):
Full Board
Expedited
Exempt
 
6. * Is this study initiated by a VCU investigator or a sponsor:
VCU Investigator initiated
Sponsor or industry initiated
 
 
The IRB has determined that the selected types of anticipated individual and social benefit apply to this study
 
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study. This information may be used by the IRB in triaging studies during an emergency
situation.
Possible or minimal direct benefit to individual participants
Scientific benefit
Educational benefit for student/trainee investigators leading their own study
 
  
 


The following information applies to studies being reviewed by the VCU IRB.
The IRB has determined that the selected Exempt and/or Expedited categories apply to this study.
The below information is read-only to investigators, and the categories are set by the IRB during review. All
categories will appear blank until the IRB has made a determination. If a category is not checked, it does not
apply to this study or the study is being reviewed by an external IRB.
7. For Expedited Studies:
Category
1
Clinical Study of
Drugs or Devices
Is a clinical study of A) drugs that do not require an IND or B) devices where an IDE is
not required or the device is being used for an approved use.
Category
5
Nonresearch Data
Collection
Involves materials (data, documents, records, or specimens) that have been
collected or will be collected solely for nonresearch purposes including medical
treatment or diagnosis.
Category
7
Behavioral
Is research that will be performed on individual or group characteristics or behavior OR
will employ a survey, interview, oral history, focus group, program evaluation, human
factors evaluation, or quality assurance methodologies.
 




HM20018316
View: SF2 - Background, Rationale and Goals
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Background, Rationale and Goals
1. * Describe the study's background and what is currently known from the scientific literature, including
citations, or upload a citation list in document upload.  Use lay language whenever possible.
General Anesthesia is an accepted Advanced Behavior Management Technique approved by the AAPD used to
accomplish extensive dental work in young and pre- cooperative children. The use of General Anesthesia in Dentistry
is advantageous because it provides – immobility, amnesia, sedation, and analgesia. Due to these effects children are
able to undergo extensive dental work in a single sitting with relative ease and little memory of the event (American
Academy of Pediatric Dentistry, 2004)
Despite the extensive use of General Anesthesia in Pediatric Dentistry no definitive guidelines exist for the use of local
anesthetic in these procedures. AAPD guidelines merely note that local anesthesia has been reported to reduce pain in
the postoperative period with marginal evidence(American Academy of Pediatric Dentistry, 2004). To date there have
been very mixed results as to the use of local anesthetic in General Anesthesia cases and usage varies. In The Use of
Local Anesthesia During Dental Rehabilitations: A Survey of AAPD Members it was shown that 51% of dentists
administer local anesthesia less then half of the time during General Anesthesia cases, 76% administered before
treatment when used, and 89% via local infiltration when used. It was also shown that Dentists and Pediatric Dentists
who completed residency training used less LA during GA cases. Last, they also showed that 21% never use LA during
GA cases and 8% always use LA during GA cases (Townsend, Martin, Hagan, & Needleman, n.d.). In Usage of Local
Anesthesia During Dental Rehabilitation With General Anesthesia: A Survey of Dental Anesthesiologists it was found
that 90% of dentist anesthesiologists prefer local anesthesia at least some of the time and 40% prefer LA use with very
rare exceptions (Townsend, Hagan, & Smiley, 2014). From these studies we can see that LA usage for dental cases
under General Anesthesia varies greatly and rationale is based on varying limited evidence.
In the literature, there are varying studies as to the effectiveness of LA intraoperatively in controlling post-operative
pain in GA dental cases. In Morbidity following dental treatment of children under intubation general anesthesia in a
day-stay unit, it was seen that children who were given LA during GA were more likely to experience postoperative
dizziness following LA. (Atan et al., 2004)The Effect of Local Anesthetic on Quality of Recovery Characteristics
Following Dental Rehabilitation Under General Anesthesia in Children showed no difference for need of postoperative
pain medication between those groups that received LA and those that did not. Additionally, in this study they found
that 20% of children treated under GA perceived postoperative discomfort due to the sensation of numbness.
(Townsend, Ganzberg, & Thikkurissy, 2009)In Perioperative local anesthetic in young pediatric patients undergoing
dental extractions under outpatient ‘short-case’ general anesthesia it was noted pain/discomfort and anxiety were not
significantly different between the groups that received LA perioperatively under GA and those that did not (Leong,
Roberts, & Ashley, 2007)This result was also observed in Local Anesthesia Effects on Postoperative Pain after
Pediatric Oral Rehabilitation Under General Anesthesia where post-operative pain in patients undergoing GA was
measured with the UPAT scale and found no statistically significant difference in post-operative pain between the two
groups(Moness Ali & Hammuda, 2019).
In Local Anesthesia Affects Physiological Parameters and Reduces Anesthesiologist Intervention in Children
Undergoing General Anesthesia for Dental Rehabilitation a statistically significant difference was seen in end tidal CO2
in the cases where dental extractions were performed. It was found that usage of LA in these cases showed better
stability of EtCO2. No statistically significance was found in observed respiratory rate and heart rate(Watts, Thikkurissy,
Smiley, McTigue, & Smith, n.d.). Very limited research is available on this subject and more research is needed to
confirm the validity of the results of this study.
American Academy of Pediatric Dentistry. (2004). Clinical guideline on the elective use of minimal, moderate, and deep
sedation and general anesthesia for pediatric dental patients. Pediatric Dentistry, 26(7 Suppl), 95–103. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/15656444
Atan, S., Ashley, P., Gilthorpe, M. S., Scheer, B., Mason, C., & Roberts, G. (2004). Morbidity following dental treatment
of children under intubation general anaesthesia in a day-stay unit. International Journal of Paediatric Dentistry, 14(1),
9–16. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/14706023
Leong, K. J., Roberts, G. J., & Ashley, P. F. (2007). Perioperative local anaesthetic in young paediatric patients
undergoing extractions under outpatient “short-case” general anaesthesia. A double-blind randomised controlled trial.
British Dental Journal, 203(6), E11; discussion 334-5. https://doi.org/10.1038/bdj.2007.724
Moness Ali, A. M., & Hammuda, A. A. (2019). Local Anesthesia Effects on Postoperative Pain After Pediatric Oral
Rehabilitation Under General Anesthesia. Pediatric Dentistry, 41(3), 181–185. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/31171068
Townsend, J. A., Ganzberg, S., & Thikkurissy, S. (2009). The effect of local anesthetic on quality of recovery
characteristics following dental rehabilitation under general anesthesia in children. Anesthesia Progress, 56(4), 115–
122. https://doi.org/10.2344/0003-3006-56.4.115
Townsend, J. A., Hagan, J. L., & Smiley, M. (2014). Use of local anesthesia during dental rehabilitation with general
anesthesia: A survey of dentist anesthesiologists. Anesthesia Progress, 61(1), 11–17. https://doi.org/10.2344/0003-
3006-61.1.11
Townsend, J. A., Martin, A., Hagan, J. L., & Needleman, H. (n.d.). The use of local anesthesia during dental


rehabilitations: a survey of AAPD members. Pediatric Dentistry, 35(5), 422–425. Retrieved from
http://www.ncbi.nlm.nih.gov/pubmed/24290554
Watts, A. K., Thikkurissy, S., Smiley, M., McTigue, D. J., & Smith, T. (n.d.). Local anesthesia affects physiologic
parameters and reduces anesthesiologist intervention in children undergoing general anesthesia for dental
rehabilitation. Pediatric Dentistry, 31(5), 414–419. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/19947137
2. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
For the purpose of this study, the following questions were addressed:
Does administration of local anesthesia at the end of restorative procedure under general anesthesia result in
decreased postoperative pain management in children?
3. * Describe the study's specific aims or goals.  Use lay language whenever possible.
Current guidelines for local anesthetic use during dental cases under general anesthesia are not specified. In the
literature there are mixed reports regarding its use some addressing solely intraoperative effects, or postoperative pain.
This study is needed due to the limited numbers of studies in the area and the lack of evidence for definitive guidelines.
In particular, in this study, I hope to address the effects of local anesthesia use intraoperatively on postoperative pain
control and irritability.
4. * Describe the scientific benefit or importance of the knowledge to be gained:
The purpose of this study is to determine the effect of local anesthesia on postoperative irritability and pain
management in dental cases under general anesthesia. This information is important because currently no guidelines
exist to define usage of local anesthetics in dental cases under GA. Current practitioner usage is due to clinical
judgement and practice varies widely across the United(Townsend, Martin, Hagan, & Needleman, n.d.). My goal is to
provide some answers to whether local anesthesia is beneficial and provide evidence if local anesthesia usage helps
control postoperative pain, and ease of recovery in PACU and home or not. This information will be obtained through
the use of pain scores pre and post operatively in the hospital, parental behavior questionnaire for postoperative
evaluation.
5. * Describe any potential for direct benefits to participants in this study:
Local anesthetic usage for dental restorative work under GA varies greatly between providers due to lack of guidelines
on the subject. It is anticipated based upon previous research that those patients that do receive local anesthesia will
have better post operative recovery and less postoperative distress. Additionally, it is anticipated, based upon the
results of previous studies that local anesthesia will provide marginal to no benefit for stability of vital signs for
restorative dentistry procedures intraoperatively.
6. * Describe any potential for direct social impact in this study . For example, any engagement with specific
communities to respond to community-identified needs, or ways the study will strengthen the well-being of
the specific communities if applicable:
There are no expected social impacts of this study.
7. Upload a supporting citation list if applicable:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
  


HM20018316
View: SF2 - Study Population
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Study Population
1. * Provide the maximum number of individuals that
  1. May participate in any study interaction or intervention (Including screening, consenting, and study
activities)
      AND/OR
  2. You obtain any data/specimens about (regardless of identifiability) 
 at VCU and at other sites under the VCU IRB's oversight. See the help text for additional guidance.
60 
2. If this is a multi-Center Project, what is the maximum anticipated number of subjects across all sites?
This study will take place at VCU Children's Hospital of Richmond through the Children's Pavillion and Brook Road
Sites. The maximum number of anticipated participants between both sites is 60 children.
3. * Provide justification for the sample size by explaining how you arrived at the expected number of
participants and why this number is adequate for answering the research questions:
This is the maximum anticipated participants that we believe we will be able to treat within out expected study timeline.
We also believe that 60 participants will provide enough data to adequately answer our research questions.
4. * List the study inclusion criteria:
Study will include patients undergoing GA for dental restorative work at VCU Children's Hospital of Richmond Pavillion
and Brook Road Centers. Study will include patients under 6 years of age. Children above 6 years of age should be
able to generally tolerate dental work in the chair if normally developing, including children older may distort data due
to behavior issues.
5. * List the study exclusion criteria:
In this study we will exclude children with any sensory or behavioral issues, as this may greatly distort data gathered.
We will exclude patients requiring extractions or surgical procedures as local anesthesia may be more beneficial in
these patients for pain and hemostasis control intraoperatively. In addition, we recommend the anesthesiologist not to
give post-operative Precedex or Ketorolac as it is not standard of care. Patients given Precedex or Ketolorac post-
operatively by the anesthesiologist will be withdrawn from the study.
6. * Will individuals with limited English proficiency be included in or excluded  from this research?
Included
Excluded - safety concerns if participants are unable to communicate with the study team
Excluded - instruments/measures only validated in English
Excluded - no prospect of direct benefit to individual participants
Excluded - minimal risk study
Excluded - lack of budget/resources for translation and interpretation [provide an explanation in next question]
Excluded - other reason [provide an explanation in next question]
7. Justify the inclusion and exclusion criteria if you are either targeting, or excluding, a particular segment of the
population / community. Provide a description of the group/organization/community and provide a rationale.
  




HM20018316
View: SF2 - Study Procedures
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Study Procedures
 
1. * Describe the study hypothesis and/or research questions.  Use lay language whenever possible.
For the purpose of this study, the following questions were addressed:
Does administration of local anesthesia at the end of restorative procedure under general anesthesia result in
decreased postoperative pain management in children?
2. * Describe the study's specific aims or goals.  Use lay language whenever possible.
Current guidelines for local anesthetic use during dental cases under general anesthesia are not specified. In the
literature there are mixed reports regarding its use some addressing solely intraoperative effects, or postoperative pain.
This study is needed due to the limited numbers of studies in the area and the lack of evidence for definitive guidelines.
In particular, in this study, I hope to address the effects of local anesthesia use intraoperatively on postoperative pain
control and irritability.
3. * Choose all types of recruitment materials that may be used and upload them below:

E-mail invitations

Phone Solicitation scripts (i.e. cold calls or random-digit-dialing)

Flyers, Mailed Letters or Newspaper/TV/Radio Ads

TelegRAM announcements

Website text

Study-specific web sites (provide the design and text)

Social Media

EPIC MyChart Patient Portal research study descriptions

Psychology Research Participant Pool (SONA) study descriptions

Scripts for announcements made to groups

Other recruitment document

No recruitment materials
4. * Describe the study procedures/methods for identifying and recruiting participants. Address all of the
following three aspects of recruitment in your response. 
1. Identification of potentially eligible participants or secondary data/specimens of interest.
     - What database(s) will be queried to identify secondary data/specimens
     - How VCU Informatics or VCU IRDS will be used for cohort identification (when applicable, see help text)
    - How potential participants' contact information will be obtained
2. Recruitment procedures to invite participation in the study (when applicable):
     - How each of the written or verbal recruitment materials and reminders (selected above) will be used
     - Who will contact, approach, or respond to potential participants
     - Locations where recruitment procedures will take place
     - The timing and frequency of recruitment attempts
3. Eligibility screening prior to consent and how those activities will be carried out (when applicable)
See the help text for additional guidance.
Patients will be recruited from patients presenting for or needing full mouth dental rehabilitation. Patients will be
recruited by doctors from VCU dental clinic and Brook Rd. Clinic during GA consultation appointment. Patients who
could be potential research participants will be given information about the research day of their consultation as well as
a consent form to review on their own time. Potential participant information will be collected and enclosed in a Google
Doc Sheet on VCU account. This would include just patient date of birth, name, MRN, phone number and surgery date.
Patients identified as potential research candidates will be approached day of surgery with the option to participate in


the research. At time of consent DOS patients will be assigned a participant number which will be used to mark record
and randomize participants. This participant number will correspond to the initial demographics collected. No additional
screening activities will be done as we already have a high volume of consultations coming through our clinics.
5. * Does this study have a separate protocol document (i.e. a multisite or sponsor's protocol) that contains a
detailed description of the study's methodology?
  Yes
No
6. * Since a separate protocol document is not uploaded, describe the proposed research using language
understandable to those IRB committee members whose expertise is not scientific. The description must
include:
 1. A statement explaining the study design
 2. A detailed description of all the procedures that will be followed to carry out the study, preferably in
sequential order, and in sufficient detail that the study's methods could be replicated
 3. The schedule and frequency of when and how procedures will be conducted (e.g. in person, online, phone,
paper, etc.)
 4. A description of all research measures/tests/interventions that will be used, including analyses/tests
conducted on specimens/biological samples (if applicable)
See the help text for additional guidance
This study has been modeled as a double-blinded randomized control trial. Patients will include healthy children (ASA
1 or ASA 2) without any history of behavioral issues under the age of 6 who had been treatment planned to have
exclusively; restorative work, prefabricated crowns and space maintainers.
Dental treatment will be performed under general anesthesia at the Children’s Hospital of Richmond Brook Rd. and
Children’s Pavilion Campuses. Sixty candidates will be recruited from patients presenting for or needing full mouth
dental rehabilitation. Patients will be recruited by doctors from VCU Pediatric Dental Clinic and Children’s Hospital of
Brook Rd. Pediatric Dental Clinic during GA consultation appointments. Participant information will be collected and
enclosed in a Google Doc Sheet on Secure VCU Server. Patients will be assigned a participant number which will be
used to randomize participants and de-identify patient information. Patients will be randomized into two groups; those
that receive LA while under GA and those that will not.
Day of surgery, patients will be evaluated preoperatively using the FLACC pain/behavior scale by the preoperative
nurse who is blinded to the candidates group in the study. Intraoperatively, patients will be given either local anesthetic
(2% Lidocaine with 1:100,000 epi) infiltration at six sites (once at each of the 6 sextants, L posterior, anterior, R
posterior on each arch) of the mouth by the dental surgeon performing the surgery or no local anesthesia will be
utilized. Administration of local anesthetic will be a weight based calculation and will be locally infiltrated 10 minutes
prior to the end of the procedure. Postoperatively patients will be evaluated in the Post Anesthesia Care Unit (PACU)
by a nurse blinded to the intervention before discharge using the same initial pain/ behavior scale, the FLACC scale,
used preoperatively. Patients will then be discharged to home when stable and parents of patients will then be given a
standard set of post-operative instructions encompassing instructions for the possibility of anesthetized tissues (see
documents). Patient’s time in the PACU will be noted upon discharge. Lastly, that evening parents were asked to
evaluate their children over the phone using a parent administered post- operative evaluation, the Parent’s Post-
Operative Pain Measure (PPPM).
7. * The IRB only reviews research activities, so indicate for each of the study activities described in the question
above or in the protocol which activities are:
  - Being performed exclusively for research purposes (i.e. they would not otherwise be done apart from this
study) VERSUS.
  - Alterations of routine activities/procedures (e.g. the study is altering the timing, frequency, method,
location, amount, etc.) VERSUS.
  - Being done for other purposes and whose data/results will be used secondarily in the study (e.g. standard
medical or psychological tests, routine education practices, quality improvement initiatives, etc.).
    See the help text for additional guidance
As part of the study patients will be assigned local anesthetic protocol based upon treatment group. Local anesthesia
use in dental cases under general anesthesia varies greatly from provider to provider. Ordinarily provider preference
would dictate use. No alteration will be made to local anesthesia routine use. Standard infiltration volumes will be used
in this study and will be administered based on a weight-based calculation. Location of local anesthetic will be
infiltrated in all 6 sextants of the oral cavity. No additional medical tests will be performed as part of the study. As part of
the study patients will have a pre- and post operative FLACC score pain assessment. This is a standard pain
assessment that is routinely preformed by nursing staff regardless of participation in the study upon patient arrival and
before patient departure. Next, throughout the study the patient will be observed by the anesthesiologist throughout the
procedure as customary and the anesthesiologist will intervene as customary by deepening the anesthetics if needed.
As part of the research patients will be contacted by postoperative phone call which is customary, however as part of
this phone call parents will be asked questions to assess patients post operative pain using the parents post operative
pain measure tool which is not customary and data will be solely collected for research.
Study specific activities:
1. Randomization to LA


2. Recording FLACC score pre/postop, time in PACU
3. Parent/guardian pain measure tool during standard postop phone call
8. If applicable, describe alternatives (research or non-research) that are available to potential participants if they
choose not to participate in this study:
If patients do not choose to participate in this study they will undergo FMDR under GA with LA as prescribed by the
dentist and anesthesiologist providing the case.
9. Upload any supporting tables or documents (e.g. protocol documents, figures/tables, data collection forms,
study communications/reminders):
Upload ALL instruments/guides that will be used or that participants will experience (i.e. see, hear, complete),
including measures, scripts/questions to guide interviews, surveys, questionnaires, observational guides,
etc,:
Upload ALL recruitment and screening materials, including such as ads, flyers, telephone or in-person scripts,
letters, email invitations, TelegRAM announcements, and postcard reminders, screening scripts, screening
forms, and screening measures:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable


HM20018316
View: SF2 - Project Details
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Project Details
An intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and
manipulations of the subject or the subject's environment that are performed for research purposes.
An interaction includes communication or interpersonal contact between investigator and subject. It may include in-person,
online, written, or verbal communications.
Secondary information/biospecimens are information or biospecimens that have been or will be collected for some other
“primary” or “initial” activity and that will be used secondarily in the research study.
1. * Select all of the following types of interventions that apply to this study (selections will branch):

Social/Behavioral interventions or experimentation / Tasks / Environmental manipulations

Deception (misleading participants through false or incomplete information)

Drug(s) / Biologics / Supplement(s) / Other Compounds (investigational products or products whose
administration is dictated by the study protocol and not per the physician's clinical judgment)

IV contrast administration for research-related imaging (will branch to the Drugs page)

Placebos

Safety and/or effectiveness evaluation of Bio-Medical Device(s), including in-vitro diagnostic devices/assays,
mobile medical apps, software functions, and HUDs used in clinical investigations

Washout Periods

Expanded Access – Treatment Use of an Investigational Product

Medical or Surgical Procedures (eg: physical exam, clinical procedures, scans, etc)

Specimen/biological sample collection

None of the Above
2. * Select all of the following types of interactions and methods of data collection that apply to this study
(selections will branch):

Surveys / Questionnaires /Written responses to questions (including data entry)

Active Internet data collection (i.e. using the internet to collect data, including online surveys, data collection via
Zoom, apps, etc.)

Passive Internet data collection (i.e. passively observing online behavior, bots)

Interviews / Focus Groups / Verbal responses to questions

Audio / Video recording or photographing participants

Observations

Educational Settings/Assessments/Procedures

None of the Above
3. * Select all types of secondary information and/or specimens that apply to this study (selections will branch):
See the help text for definitions.

Individually Identifiable Health Information (PHI)

Secondary data/specimens NOT from a research registry or repository

Information/specimens from a research registry or repository (Usage Protocol)

Information/specimens originally collected for a previous research study

Publicly available information/specimens



Government-generated or collected information that was or will be obtained for nonresearch activities [only
applicable to research conducted by or on behalf of a Federal department or agency]

No secondary data/specimens will be used
 


HM20018316
View: SF2 - Bio-Medical Drug / Biologic / Supplement / Other Compound Details
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Bio-Medical Drug / Biologic / Supplement / Other Compound
Details
1. * List all drugs and/or biologics:
 
Drug
ManufacturerTypes
FDA
Labeling
IND
Holder
IND
Number
View 2% Lidocaine with
1:100,000 epinephrine
Henry Schein
FDA Approved and being
used as approved
Yes
Not
Required
IND Exempt
2. * Will the Investigational Drug Service (IDS) pharmacy be utilized:
Not Applicable
3. * A. For each drug/biologic listed above, upload an investigator's drug brochure or package insert/FDA labeling.
B1. For drug products that require an IND, upload at least one of the following for verification of the IND
number:
  - External sponsor's protocol including IND number and signed Form FDA 1572 for the VCU Principal
Investigator
  - Communication from the external sponsor verifying the IND number and signed Form FDA 1572 for the VCU
Principal Investigator
  - VCU sponsor-investigator's FDA IND protocol including IND number
  - Communication from the FDA with verification of the IND number
B2. For drug products that qualify for IND exemption under under 21 CFR 312.2(b), upload one of the following
for each applicable drug:
  - A document explaining, with protocol-specific information, how the drug's use in this study meets the
relevant criteria for IND exemption under 21 CFR 312.2(b).
  - The completed "Determination of IND Exemption for Marketed Drugs" form available on the VCU Faculty‐
Held IND or IDE website at go.vcu.edu/indide.
  - External sponsor's protocol including IND exemption information
  - Communication from the external sponsor verifying the IND exemption
  - Communication from the FDA with verification of IND exemption
C. If the Investigational Drug Service Pharmacy (IDSP) is not utilized, upload the IDSP management plan
approval.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Collection
Packet
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
 


HM20018316
View: SF2 - Secondary Data/Specimen Details
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Secondary Data/Specimen Details
1. * Describe the source(s) and nature of the information/specimens being obtained. This response should:
  a. Identify where the data/specimens will come from (e.g., another researcher's registry, pathology lab,
commercial source, medical records, etc.); and
  b. List what types of specimens will be obtained (when applicable); and/or
  c. List all data elements that will be obtained (when applicable). A data collection form or other
documentation may be uploaded and referenced here.
Data will be collected in a data collection packet. Pre-operatively Nurses in Pre-Op will record FLACC score from the
patients chart into the data collection packet. Post- operatively Nurses in Post-op will record FLACC score from the
patients chart into the data collection packet. Time in PACU will also be collected.  
2. * Describe whether any agreement exists between you and data/specimen provider that states you will never
have access to the ability to identify the participants (i.e. access to identifiers or the code key) and that you
will not attempt to re-identify individuals.
Information collected throughout the study on the data collection form will be de-identified and labeled with participant
number. Patient identifiers will be stored on secure VCU google drive including patient name, mrn, date of birth, day of
surgery,participant number and patient phone number. Patient data will not be re-identified. Patient identifiers will be
used merely to access data from the anesthetic record and dental record.
3. * When the information/specimens were originally collected, did individuals provide consent for secondary
research use of their data/specimens (i.e. consent to another research study or to a research registry)?
  Yes
No
 


HM20018316
View: SF2 - Costs to Participants
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Costs to Participants
1. * Select all categories of costs that participants or their insurance companies will be responsible for:

Participants will have no costs associated with this study

Study related procedures that would be done under standard of care

Study related procedures not associated with standard of care

Administration of drugs / devices

Study drugs or devices

Other
2. * Provide details of all financial costs to the participant, other than time and transportation. Additional details
regarding standard of care costs will be requested on another screen, if applicable.
None
3. * Describe any procedures, therapy, lab work, x-rays, drugs, or devices, etc that are considered standard of
care and will be charged to the participant or their insurance.
Cost of Full Mouth Dental Rehabilitation under General Anesthesia with necessary Full Mouth Series Radiographs as
standard part of their dental treatment they are scheduled to receive
4. * Describe the process to determine whether participants' insurance will cover the expenses.
Patient insurance will be pre-authorized before scheduling of procedure and before selection for study.
 


HM20018316
View: SF2 - Compensation
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Compensation
It is recommended that investigators consult with VCU Procurement Services before proposing a compensation plan
(monetary or non-monetary) to the IRB to ensure the plan will comply with VCU policies. Refer to WPP XVII-2 for the IRB’s
guidelines about compensating research participants.
1. * Describe any compensation that will be provided including:
   1. total monetary amount
   2. type (e.g., gift card, research pre-paid card, cash, check, merchandise, drawing, extra class credit)
   3. how it will be disbursed
   4. how you arrived at this amount
   5. What identifiers and tax forms will be required for compensation purposes (i.e. W-9 form, SSN, V#,
addresses, etc.)
None
2. If compensation will be pro-rated, explain the payment schedule.
 


HM20018316
View: SF2 - Contingency Plan
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Contingency Plan
This page will be used by the IRB in the event that an institution-wide emergency situation arises that requires
contingency plans. 
A contingency plan describes the alternative procedures that a study would want to use in case of an emergency that
prevented normal study activities from occurring. It is a form of adaptive protocol. It enables the VCU IRB to quickly
approve alternative study activities along with criteria for when those activities would or would not be put into effect.
For example, in 2020, some studies had a COVID-19 Contingency Protocol approved that described alternative
remote procedures that they would switch to whenever the University restricted in-person research activities.
In all studies, investigators are strongly encouraged to plan prospectively and build flexibilities into their regular
protocols (regardless of whether an emergency situation exists) as well as think about what they would do in an
emergency situation. For example, windows for timed study visits, ranges instead of exact values, flexibilities in
inclusion criteria, etc. Flexibility and adaptations that are built into the protocol will reduce the number of changes
that have to be submitted to the IRB and should reduce the number of incidents of deviations and noncompliance by
investigators.
Further instructions and smartform questions on this page will be released from the IRB in the event of such an
institution-wide emergency situation.
 




HM20018316
View: SF2 - Consent Process
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Consent Process
1. * List all consent groups:
 
Group Types
Waivers
Roles
Roles
-
Other
Electronic
SignaturesConsent
Coercion Decision Re-
Consent
View Parent/
Guardian
Consent
Signed
Parent/Guardian
Permission or
Legally
Authorized
Representative
Consent
Short Form
Consent (limited
applicability)
No
Waivers
Requested
Principal
Investigator
Lead
Student/Trainee
Investigator
(leading their
own project)
Co/Sub-
Investigator
 
Not using
electronic
signature
platforms
Parents will
be initially
presented
with the
option to be
considered to
participate in
the study at
the end of
their
consultation
for surgery
visit. Parents
will be
provided with
a copy of the
consent form
on that date.
Parents will
be asked to
sign consent
day of
surgery
preoperatively
Other
protection(s)
not listed
here –
describe
below
Parents of
patients will
be asked to
participate
in the study
at the close
of their
consultation
for surgery.
Parents of
patients will
have the
time from
the date of
consultation
to the day
of surgery
to decide if
they would
like to
participate
in the study.
 
2. Upload any consent / assent documents:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
  


HM20018316
View: SF2 - Short Form Consent
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Short Form Consent
Consent groups that require a short form consent document:
Groups Types
Waivers Roles
Roles
Other Consent
Decision
Status
Change
Parent/
Guardian
Consent
Signed
Parent/Guardian
Permission or
Legally Authorized
Representative
Consent
Short Form
Consent (limited
applicability)
No
Waivers
Requested
Principal
Investigator
Lead
Student/Trainee
Investigator
(leading their
own project)
Co/Sub-
Investigator
 
Parents will be initially
presented with the
option to be considered
to participate in the
study at the end of their
consultation for surgery
visit. Parents will be
provided with a copy of
the consent form on that
date. Parents will be
asked to sign consent
day of surgery
preoperatively
Parents of patients
will be asked to
participate in the
study at the close of
their consultation for
surgery. Parents of
patients will have the
time from the date of
consultation to the
day of surgery to
decide if they would
like to participate in
the study.
 
1. * A Short Form written consent stating that the elements of consent have been presented orally to the
participant or Legally Authorized Representative 45 CFR 46.117(b)(2). Does the PI certify that all of the
following will occur:
1) A witness will be present to observe the consent process
2) The Short Form will be signed by the participant or the Legally Authorized Representative
3) The witness will sign both the Short Form and the Summary
4) The person obtaining consent will sign the Short Form and the Summary
5) The participant will sign the Short Form
6) A copy of the Summary and the Short Form will be given to the participant or Legally Authorized
Representative
  Yes
No
2. * Explain why you are requesting to use a short form consent form:
We will only be using a short form consent for those few individuals in the study for whom english is not the primary
language and a translator will be utilized for the consent.
 




HM20018316
View: SF2 - Risks, Discomforts, Potential Harms and Monitoring
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Risks, Discomforts, Potential Harms and Monitoring
1. * Describe the risks of each research procedure to participants or others. For each identified risk, provide an
assessment of the anticipated seriousness and likelihood of the risk. Some examples of possible risks include
but are not limited to:
Physical risks (e.g. bodily harms or discomforts, side effects, etc.)
Psychological risks (e.g. emotional, mental, or spiritual harms or discomforts, changes to thoughts,
beliefs, or behaviors, etc.)
Research data risks (e.g. loss of confidentiality and privacy)
Social or legal risks (e.g. impacts on relationships or reputation, legal or criminal justice actions for self
or others, etc.)
Financial risks (e.g. impacts on income, employability, or insurability, loss of services, etc.)
Other risks (e.g. unforeseeable risks of experimental procedures, risks related to particular study
designs (randomization, washout, placebo, withholding care/services, deception), etc.)
See the help text for additional guidance.
Local anesthesia is routinely used in dental treatment and can lead to short term post operative numbness. In patients
that will receive local anesthesia they will have transient numbness that can lead to some discomfort due to the
temporary altered sensation in the area. Additionally due to the numb sensation some patients can cause inadvertent
self inflicted trauma in the area. Additionally, throughout the course of this study there is a risk of loss of confidentiality
thorough lost or shared information. Last, anticipate the risk of survey completion that being asked survey questions
may cause distress or anxiety since their child will be evaluated. In addition, as part of a randomized control trial
groups will be randomized using block randomization- participants will not be able to choose their protocol once
enrolled in the study.
2. * Describe how each of the risks/harms/discomforts identified above will be minimized:
These risks will be minimized by first, all parents will be provided the same written and verbal post operative
instructions including information advising parents that portions of the child's mouth may be numb and they should
monitor them closely for the next few hours to ensure of no lip of tongue biting. Second, clinical data stored will be de-
identified and stored on a secure VCU server database. Lastly, surveys performed on child will be done through pure
objective scale. No questioning will be directed towards child. At home survey will be directed at parents and includes
commonly utilized post operative questions to assess how a child is doing after surgery and provide the best post
operative guidance (ex. diet, activity, pain management). To minimize the risk of bias block randomization will be
utilized and patients will receive post operative instructions encompassing post operative guidance (e.g post operative
instructions reviewing local anesthesia will be given to all participants even if it was not utilized.)
3. * Describe any potential risks or harms to a community or a specific population based on study findings (e.g.
information that could be stigmatizing or derogatory):
No potential risks or harms to a specific community anticipated.
4. Where appropriate, discuss provisions for ensuring necessary medical, professional, or psychological
intervention in the event of adverse events to the subjects:
Patient will be monitored by both dentist and anesthesiologist throughout the entirety of the case and monitored by the
nurses post operatively. Any medical interventions will be performed by these personnel if necessary. No psychological
intervention anticipated.
5. * Describe criteria for when the investigator would withdraw an individual participant from the study; such as
safety or toxicity concerns, emotional distress, inability to comply with the protocol, etc.:
After a patient has been accepted in the study and consent obtained patients will only be withdrawn if it is determined
during comprehensive exam under GA if a patient requires EXT of any teeth. In that case patient will have local
anesthesia administered in the area of extraction, extraction will be performed and patient will be withdrawn from the
study. Patients given Precedex or Ketolorac post-operatively by the anesthesiologist will be withdrawn from the study.
These are given based on anesthesia provider's preference. The protocol will discourage the use of these medications
for study participants as it would alter the effects of the intervention.
6. * Summarize any pre-specified criteria that would trigger the investigator/sponsor/monitoring committee to
stop or change the study protocol due to safety concerns:


None anticipated. Study is evaluating methods that are currently utilized to evaluate which has better patient response.
No safety concerns anticipated as lidocaine 2% with 1:100,000 epi is routinely used
by some providers in FMDR under GA.  
Data and Safety Monitoring
Data and safety monitoring is a system for checking the study’s data at regular intervals over the study period
to identify and address issues that could affect the safety of research participants. This requirement is in
accordance with 45 CFR 46.111.
The purpose of data and safety monitoring plan is to set forth study team procedures for
monitoring/addressing:
- Participant safety (physical, psychological, etc.)
- Data validity
- Early stopping (termination) based upon changes in risks and benefits.
7. * Indicate if this study will have a Data Safety Monitoring Board (DSMB) or a Data Safety Monitoring Plan
(DSMP): [Required for all greater than minimal risk studies]

DSMB

DSMP

No DSMB/DSMP [Note: This response is not applicable for greater than minimal risk studies]
 


HM20018316
View: SF2 - Privacy
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Privacy
Privacy refers to an individual’s right to control how others view, record, or obtain information about them. When
privacy is violated it can involve such things as
Being asked personal questions in a public setting;
Being publicly identified as having a particular characteristic or diagnosis;
Being seen entering a place that might be stigmatizing;
Being photographed, videotaped or observed without consent;
Disclosure of personal information to unauthorized people
Privacy is not the same as confidentiality because privacy protections apply to people, and confidentiality
protections apply to data. Confidentiality protections should be described on the Data Confidentiality page of this
form, not here.
Instructions for this page:
Select all the applicable ways that the research team will protect participants' privacy throughout the course of the
study. The options listed include some of the most common best practices. Not all will be applicable to every study. 
**The IRB will expect studies to operationalize all selected checkboxes into the conduct of the research.
To elaborate on any response, also click the “Other Protections” checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections when conducting one-on-one in-person interventions or interactions (for groups see Q2 below):

Conducting study activities in locations that maximize privacy (limited people around, closing doors,
drawing drapes around beds, monitoring voice volume, etc.)

Verifying identity before discussing personal information.

Asking the participant if they are comfortable answering questions in that location

Asking the participant if they are comfortable with having other people present (if any)

Moving away from other people when conducting activities in public spaces or offering a private space

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing) if
uncomfortable verbally responding

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Other protections not listed in this question – describe below

N/A – study has no in-person interventions or interactions with participants
 
2. * Protections when conducting group interventions or interactions:

Conducting study activities in locations that maximize privacy (limited people passing by, closing doors,
monitoring voice volume, etc.)

Moving to a more private area to answer questions or to discuss concerns

Discussing privacy with the participants and the importance of not talking outside the group about what other
people say during the group session

Allowing participants to use a pseudonym or limiting use of individuals’ names during the group activity

Asking everyone in a public group setting (e.g. classrooms, workshops) to turn something in (blank or filled) so
participants do not have to self-identify when turning in materials

Collecting paper forms in a closed box or envelope rather than passing to others or leaving in an open area



Limiting participant identifiers that would be visible on paper documents (i.e. using study IDs instead of direct
identifiers)

Allowing people to distance themselves from other participants during group activities

Offering other options of ways to respond to sensitive questions (i.e. pointing, clicking, or writing instead of
speaking)

Using generic signs on research rooms and spaces, particularly for research on stigmatizing or sensitive topics

Ensuring non-participating individuals are not captured on recordings or in photos

Other protections not listed in this question – describe below

N/A – study has no group interventions or interactions
 
3. * Protections when conducting remote interventions or interactions (e.g. phone, text, email, video-conference,
tele-health, online, etc.):

Conducting study activities in locations where study staff can maximize their own privacy (limited people around,
closing doors, monitoring voice volume, etc.)

Leaving/sending generic messages that avoid using study and participant identifiers, such as names, study
titles, clinics, study topics, etc.

Obtaining permission prior to sending text messages

Advising the participant to move to a location where they are comfortable answering questions and will not be
overheard - incorporate this instruction into your study materials

Advising online participants to complete the activity at a time and location where they will be comfortable
answering questions - incorporate this instruction into your study materials

Ensuring non-participating individuals are not captured on recordings or in photos

Offering other options of ways to complete the activity (i.e. online, paper, phone) if more privacy is desired

Offering a way to save and return later to the online activity if privacy is compromised

Other protections not listed in this question – describe below

N/A – study has no remote interventions or interactions with participants
 
4. * Protections when mailing study materials to/from participants:

Obtaining permission to mail study materials

Confirming/verifying the accuracy of addresses before mailing items

Ensuring the participant is able to personally receive mailed materials and has a way to protect their own privacy
if they do not want others to know they are receiving research communications (i.e. notifying participants of
when to expect it)

Using return address labels and document headers that avoid study identifiers, such as study names, clinics,
study topics, etc.

Avoiding or limiting use of participant identifiers and health information on mailed documents (i.e. using study
IDs instead of direct identifiers)

Providing a return mailing address label or pre-addressed envelope to ensure returned items are sent to the
correct address

Communicating receipt of mail from participants and/or asking them to notify you when they mail it to ensure
study documents are not lost in transfer

Offering other options of ways to complete the activity (i.e. by phone or online) if desired

Other protections not listed in this question – describe below

N/A – not mailing any materials to/from participants
 
5. * Protections when analyzing or disseminating study data *Applicable to all studies*:

Working only in locations where the study team can ensure privacy (not working in close proximity to
non-study personnel, closing doors, closing/putting away documents/files before leaving, etc.)

Securing physical materials only in locations that ensure privacy (access limited to authorized study
personnel)



Obtaining explicit parental permission before disseminating or sharing recordings or photos of children

Blurring/redacting/hiding faces and other identifiable features/marks (tattoos, scars, birthmarks, distinctive voice,
etc.) in recordings or photos prior to disseminating or sharing

Only publishing or presenting aggregate results or findings (i.e. no individual-level information)

Taking additional steps to protect participant identities when publishing or presenting individual-level information,
quotations, results, images – describe below

Other protections not listed in this question – describe below
 
6. Describe any other way(s) that the research team will protect participants' privacy. See the help text for
additional guidance.
Patients will be identified for the study during routine dental consultation for GA. For the consultation
patients will be seen in a dedicated dental cubicle. Each patient will be seen in their own cubicle and this is where all
information will be collected and the research will be discussed. No screening or recruitment activities will be
performed. All participant demographic information will be collected on a secure VCU google Doc with the patient name
and their participant number. All information collected during the study will be collected on a de-identified data
collection form Day of Surgery. After collection, data collection forms will be stored in locked storage. Data will be
inputed from data collection form and will be stored on secure VCU Google Docs with de-identified information.
Informed consent for the study will be obtained day of surgery. Parents will be consented in their child's preoperative
room in PACU by the Nurse using a script and research flow sheet. Patients will be assigned a research candidate
number and all data collected will be de- identified through use of this number. All data will be initially be collected on a
data collection for day of surgery. After surgery data collection form will be placed in locked storage until it is imputed
and stored digitally on VCU protected data bases - red cap survey software and google sheets. After data is imputed
Data collection sheets will be disposed of at VCU clinic in Secure locked shed container. Data will be accessed by
Research members only through secure access to VCU sheets. Only those on research team will have access to view
and edit data on sheet and red cap survey software.
  


HM20018316
View: SF2 - Data Confidentiality and Storage
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Data Confidentiality and Storage
Confidentiality refers to the way private, identifiable information about a participant or defined community is
maintained and shared. It describes how the study’s research materials (data, specimens, records, etc.) are protected
from unauthorized access.
Instructions for this page:
Select all the ways that the research team will keep the study materials and data confidential throughout the course
of the study. Not all will be applicable to every study. 
To elaborate on any response, also click the “Other Protections” checkbox to provide further explanation in the last
free-text question.
Read the entire page before filling out the form.
1. * Protections for paper research materials:

Maintaining control of paper documents at all times, including when at an off-campus location

Limiting or avoiding use of participant identifiers on paper documents (i.e. using study IDs instead of
direct identifiers)

Storing paper documents in a secure location accessible only to authorized study personnel

Promptly transcribing, scanning, or abstracting data from paper into electronic platforms with
destruction of the paper copy

Proper destruction of paper records (and obtaining prior permission when required) in accordance with
VCU Records Management policies

Other protection not listed in this question – describe below

N/A – no paper research materials
2. * Protections for research specimens:

Maintaining control of specimens at all times, including when at an off-campus location

Storing specimens in a secure location accessible only to authorized study personnel

Labeling specimens with subject ID or other coded information instead of direct identifiers

Final destruction of specimens will be in accordance with VCU policies and specimen containers will be devoid
of any identifiable information

Other protection not listed in this question – describe below

N/A – no research specimens
3. * Protections for electronic files/data - See https://ts.vcu.edu/about-us/information-security/data-management-
system/

*Required for all studies* Use VCU-approved methods of data storage, transmission, and transfer (see
https://dms.vcu.edu)

Remotely accessing VCU network storage to store data when at off-campus locations

Ensuring unauthorized individuals who might share a device do not have access to study materials (e.g.
individual logins, separate accounts)

Using VCU-approved data collection tools and apps (e.g. REDCap) and storing exported analysis files in
VCU-approved storage locations (see https://dms.vcu.edu)

When using non-VCU-approved electronic data collection tools, storage locations, data transfer platforms, and
mobile apps (e.g. Dropbox, Box, Survey Monkey, Fitbits, novel apps, multi-site data collection platforms):
• consulting with VCU Information Security on proper data management (see https://ts.vcu.edu/askit/essential-
computing/information-security/);
• advising participants about the terms of use and privacy policies of those sites/apps;
• limiting or avoiding use of identifiers; and
• removing data promptly from the external location after transferring it to a VCU storage location

De-identifying the research data by replacing subjects’ names with assigned subject IDs

Storing the study’s linkage key in a password-protected and VCU-approved storage location (see
https://dms.vcu.edu)



When analyzing particularly sensitive information, using computers that are unconnected from the internet.

Proper destruction of electronic records (and obtaining prior permission when required) in accordance with VCU
Records Management policies

Other protection not listed in this question – describe below
4. * Protections for computers and research devices/apps that are provided to participants for use in the study
and taken out of the lab (i.e., giving participants a phone or iPad to take home, wearable trackers, apps, etc.):

Transferring data promptly from the device/app given to the participant to a VCU storage location

Setting strong passwords on computers and research devices (when applicable) that leave VCU with
participants

Device/app set up by VCU Information Security

When providing devices or mobile apps to children, informing parents about the settings and how to manage
them (if applicable), internet access, and any other installed apps on the device

Other protection not listed in this question – describe the device/app and protection below

N/A – no computers or devices/apps being provided for participant use outside the lab
5. * Protections for email/online communications

Only using VCU/VCU Health email addresses for study-related communications

Only using VCU/VCU Health–approved methods of teleconferencing or video conferencing (e.g. Zoom) (for
studies involving HIPAA, contact VCU or VCU Health Information Security [as appropriate] about HIPAA-
compliant systems)

Other protection not listed in this question – describe below

N/A – no email/online communications
6. Specify any other places where this study’s paper and electronic research data and/or physical specimens will
be stored and any other ways they will be secured from improper use and disclosure. 
See the help text for additional guidance.
Participant contact information will be stored on VCU secured google sheets with associated research participant
number. Research Data will be initially collected Day of Surgery on a Data collection packet. data Collection packet will
be collected and scanned and data input on VCU secured google docs identified through date of collection and
research participant number. After scanning paper surveys original copies will be shredded. Up until that time data will
be stored, de-identified in a folder locked in office desk at VCU Pediatric Dental Clinic. Data collected will be stored
digitally on red cap and vcu google sheets associated solely with research participant number. Consents will be kept in
folder locked in office dental at VCU Pediatric Dental Clinic. After surgery data
collection form will be placed in locked storage until it is imputed and stored digitally on VCU protected
databases - red cap survey software and google sheets
7. * If research data/specimens will be sent/released to person(s) or group(s) outside of the VCU study team or
the PI’s department for the conduct of this protocol (not for future sharing),
1) identify the data/specimen recipient(s) along with their VCU department or other institutional or
organizational affiliation(s).
2) give a description of what identifiers and/or codes will accompany the data/specimens.
If data/specimens are not being sent/released outside of the VCU study team or the PI’s department, state that:
Research data will not be shared with anyone outside of the VCU study team.
8. * Select all identifiers that will be collected at any time as part of this study (including for recruitment, data
gathering, data analysis, etc.), even if the data will eventually be anonymized:

Names

Geographic Locators Below State Level

Social Security Numbers

Dates (year alone is not an identifier)

Ages over 89 (age under 89 is not an identifier)

Phone Numbers

Facsimile Numbers

E-mail Addresses

Medical Record Numbers



Device Identifiers

Biometric Identifiers

Web URLs

IP Addresses

Account Numbers

Health Plan Numbers

Full Face Photos or Comparable Images

License/Certification Numbers

Vehicle ID Numbers

Other Unique Identifier

No Identifiers

Employee V#
9. If "Other Unique Identifier" was selected above, describe the identifiers:
Date of Birth, Patient age- all patients in study ages 6 and under.
10.   * If the study will code (i.e. de-identify) the research data by replacing subjects’ names and/or other identifiers
with assigned subject IDs, explain the following aspects of the coding process:
- The process for how subject IDs will be generated/assigned (e.g. random, sequential)
- Whether there will be a key that links the subject ID with direct identifiers. If there will be no linkage key, state
that.
If a key will be created, describe
- The place where the key will be stored
- The role(s) of all individuals who will have access to the key
- When the key will be destroyed
See the help text for guidance.  
Patients will be assigned sequential research participant numbers which will serve as the subject ID # and will de-
identify the research data from the participant. A key will be made which will include patient information associated with
research participant number. This key will be stored in VCU secured google sheets and will be stored in a separate
digital VCU sheet than the data collected. Only those investigators involved in the study will have access to the key.
Key will be destroyed at the conclusion of the study after the study has been published.


HM20018316
View: SF2 - Data Retention
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Data Retention
1. * Select all of the ways that individually identifiable information obtained during pre-screening and/or
screening will be handled for individuals who DO NOT qualify for the study:

N/A - study does not require screening procedures

Immediately destroy the information and identifiers (no data collected)

Immediately destroy the identifiers connected with the data (anonymization)

Store until the end of study & then destroy

Use as "screening failure" data by members of the study team

Provide to others outside of the research team (with the participant's permission)

Request permission from participant to maintain and use the identifiable information

Other
2. * Will participants be able to withdraw their data (paper, electronic, or specimens) from the study (e.g. ask that
it be destroyed or returned) if they no longer wish to participate? (FDA-regulated studies should select No –
see help text)
  Yes
No
3. * If Yes , describe the process (oral, written, email, letter, etc.) that participants should use to request
withdrawal of their data/specimens. Identify if there is a timepoint when withdrawal will no longer be an option
and/or if the amount of data that can be withdrawn is reduced at different points in the study.
Patients can withdraw from the study by orally stating they wish to do so. Patients have the option to withdraw from the
study up until patient has left pre-operative area.
4. * What will happen to the research materials (e.g. data, specimens, documents, etc.) when the research has
been completed?
Stored indefinitely with identifiers removed
Stored indefinitely with identifiers attached
Destroyed at the end of study once the minimum time required for data retention has been met per VCU
Data Retention Policy and/or sponsor retention requirements
Destroyed when notified by sponsor but not less than the minimum time required for data retention per VCU
Data Retention Policy
Other
 
  


HM20018316
View: SF2 - Sharing Plan
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Sharing Plan
This page addresses times when investigators may be required to share information about participants or may desire
to share their research information/specimens with the aim of advancing science. This page creates a plan for when
and how information/specimens could be shared.
Try to anticipate all reasonably foreseeable sharing so that the consent document can also reflect that information.
However, it is acceptable to amend this page later and explain either how re-consent of previously and currently
enrolled participants will occur or why re-consent should not be required.
The IRB reviews this page against the consent document (if one exists) to demonstrate the ethical principle of
Respect for Persons by confirming that plans for sharing do not go against what participants would understand
about the use of their data/specimens.
The IRB also ensures there are adequate protections for the privacy of participants and the confidentiality of
participants' data/specimens when data is shared with others.
1. * Is it likely investigators could discover information about child/elder abuse or neglect that would require
mandatory reporting by the investigators or staff?
The Code of Virginia requires that most medical personnel and all employees of institutions of higher
education report suspected child/elder abuse or neglect.
  Yes
No
2. *  Is it likely investigators could discover a previously unknown reportable disease or condition that would
require mandatory reporting by the investigators or staff (i.e., HIV , coronavirus, hepatitis, etc.)?
  Yes No
3. * Will the sponsor or investigator obtain a Certificate of Confidentiality for this study?
Certificates of Confidentiality  (CoC) are issued by the National Institutes of Health (NIH), the FDA and CDC to
protect identifiable research information from forced disclosure. All human subject research studies
regardless of funding can qualify to receive a CoC. A CoC is automatically issued for research that was
ongoing on December 13, 2016. or initiated after that date. For more information, see
https://humansubjects.nih.gov/coc/
No – Will not obtain CoC for this study
Yes – CoC has been obtained or issued automatically
Yes – CoC request is pending
4. * Select the way(s) that information or biospecimens (including DNA) may be used by the VCU PI or VCU study
team for other future research projects (i.e. analyses beyond/apart from the aims of this study)?
See help text for definitions.

Will use directly identifiable information or specimens.
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research is treated as a
registry by the VCU IRB. The IRB must approve the new research use in an amendment to this study or as part
of a new study before the project is initiated. VCU IRB studies will be asked more questions about this on a later
page)

Will use de-identified or indirectly identifiable information or specimens.
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. When the


researcher holds both the data and the key, the VCU IRB considers the subjects to be readily identifiable.
Maintaining identifiable data for future research uses is treated by the IRB as a registry. The IRB must approve
the new research use in an amendment to this study or as part of a new study before the project is initiated.
VCU IRB studies will be asked more questions about this on a later page)

Will use anonymized information or specimens.
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified, i.e. no direct or indirect identifiers or identifiable combinations of variables. The VCU
IRB considers uses of anonymized data/specimens to not be human subject research.)

Will use aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects.)

Will contribute to an existing registry or repository
(VCU IRB studies will be asked more questions about this on a later page.)

Will not use information/specimens for purposes beyond this study.

Not sure and will submit an amendment when known

Other use(s) of individual-level information in a way not listed above
5. * Select the way(s) the VCU PI/study team may share information or biospecimens (including DNA) with other
researchers who are not on this study team (i.e. for analyses beyond/apart from the aims of this study). 
See help text for definitions.

Will share directly identifiable information or specimens with other researchers.
(‘Directly identifiable’ means that identifiers like name, medical record number, social security number, etc. are
included in/attached to the dataset/specimens. Maintaining identifiable data for future research uses is treated
by the VCU IRB as a registry. The data recipient’s use of identifiable data would require them to obtain IRB
review. VCU IRB studies will be asked more questions about this on a later page.)

Will share de-identified or indirectly identifiable information or specimens with other researchers.
(‘De-identified’ means that a linkage/key code exists that links identifiers to data/specimens. The VCU
researcher maintains the key but does not share it with any other researchers. The recipient’s use of de-
identified data/specimens may not be human subject research if there is documentation that the key will never
be shared with the recipient, but they should check with their own IRB about review requirements. VCU IRB
studies will be asked more questions about this on a later page.)

Will share anonymized information or specimens with other researchers.
(‘Anonymized’ means that 1) no linkage/key codes exist that link identifiers to data/specimens; and 2) subjects
cannot be readily identified (i.e. no direct or indirect identifiers or identifiable combinations of variables). The
VCU IRB considers uses of anonymized data/specimens by other researchers to not be human subject
research, but the recipient should check with their own IRB about review requirements.)

Will only share aggregate results (summary-level results), not individual-level information or specimens.
(The VCU IRB considers uses of aggregate data to not be human subject research because there are no
individual subjects. The data recipient should check with their own IRB about review requirements.)

Will contribute to an existing registry or repository (VCU IRB studies will be asked more questions about this on
a later page.)



Will submit data to an NIH genomic data repository (VCU IRB studies will be asked more questions about this on
a later page.)

Will not share information/specimens with other researchers.

Not sure and will submit an amendment when known

Other sharing of individual-level information with other researchers
6. * The Principal Investigator certifies that after the study has been closed with the VCU IRB, the following
conditions will be met whenever individual level research information and/or specimens are used or shared:
  - The identities of participants who are represented in the dataset/specimens will not be readily ascertainable
or otherwise re-identifiable by the recipient;
  - If a linkage/code key is created, it will be maintained at VCU and not shared with the recipient under any
circumstances;
  - The PI will have no knowledge that the remaining information could be used alone or in combination with
any other information to identify the individuals represented in the data; and
  - The PI agrees to abide by this sharing plan even after the study has been closed with the VCU IRB.
Yes
No
N/A - No sharing will occur
  


HM20018316
View: SF2 - Pertinent Results and Incidental Findings
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Pertinent Results and Incidental Findings
1. * Is it likely investigators could discover a participant's previously unknown condition (e.g. pregnancy,
disease, suicidal thoughts, wrong paternity, genetic results, or other findings that may be of importance to
health or well-being) or if a participant is engaging in illegal or reportable activities:
  Yes
No
 




HM20018316
View: SF2 - Populations with Special Considerations
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Populations with Special Considerations
1. * Check all participant groups that will be either
  a) Specifically included in this study or
  b) Discernable in the research data/specimens.
  (Selections will branch)

Children

Emancipated minors

Wards of the State

Pregnant women or fetuses

Neonates or Post-delivery Materials

Prisoners

Decisionally Impaired Adults

VCU / VCUHS students or trainees

VCU / VCU Health System employees

Individuals with limited English proficiency

Active military personnel

Student populations in K-12 educational settings or other learning environments

Members of a federally recognized American Indian and Alaska Native tribe

None of the Above
 
           
           


HM20018316
View: SF2 - Children
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Children
1. * Check all that apply to the study:

45 CFR
46.404
Research involving no greater than minimal risk to children, with adequate provisions for
soliciting the assent of the children and permission of their parents or guardians, as set forth
in Sec. 46.408

45 CFR
46.405
Research involving greater than minimal risk but presenting the prospect of direct benefit to individual
participants

45 CFR
46.406
Research involving greater than minimal risk and no prospect of direct benefit to individual
participants, but likely to yield generalizable knowledge about the participant’s disorder or condition

45 CFR
46.407
Research not otherwise approvable which presents an opportunity to understand, prevent or alleviate
a serious problem affecting the health or welfare of children. (Research in this category must be
reviewed and approved by the Secretary of the Department of Health & Human Services)
2. If multiple categories are selected above, explain which study groups are covered by each selected category
(e.g. treatment vs. control groups):
3. * Describe how you plan to obtain permission of parents or legal guardians. If you have indicated this study
will fall into categories 406 or 407, please describe here how you will obtain permission from both parents.
Consent will be obtained by parents day of surgery as part of the written consent day of surgery for dental procedures
under GA.
4. * Describe how children will be assented to participate in the study (i.e. what will the study team do during the
assent process to ensure the child understands what the research involves).
Children included in the study will be under 6 years of age. Due to patient cognitive level at this stage in development
assent will not be obtained directly from research participants.
 


HM20018316
View: SF2 - Limited English Proficiency
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Limited English Proficiency
1. * Describe how Non-English speaking or limited English proficiency participants will be able to communicate
with the study staff at enrollment and throughout the study. Include the following information:
    - how the initial informed consent process will be handled
    - how the research team plans to interact with LEP participants throughout the conduct of the study
    - whether there will be a qualified interpreter or assistive translational devices available
    - whether the study consent document will be translated or a short form consent document will be used
    - the names of the individuals or professional groups who will provide oral interpretation or written
translation services, and their qualifications
For patients initial consultation, patients will be seen in the dental clinic for translation purposes we will utilize either the
professionally trained VCU hospital interpreters, MARTI video interpreters or the CyraCom interpreter network phone
service. At this initial consultation patients and their parents will be informed of the research study. Protocol and
consent will be reviewed with translator assistance. Day of surgery patients will be again approached with the option of
participating in the study. For translation day of surgery we will utilize either professionally trained VCU hospital
interpreters, MARTI video translation service or the CyraCom interpreter network phone service. It is anticipated that
our study will include less than 5% LEP subjects so a short form consent document will be used and included as part of
our consent.
 
2. * Describe any additional risks or harms to the individual because of their limited English proficiency and how
these will be minimized.
No additional risks are interpreted because professional medical translation services will be utilized.
3. If an interpreter or translator will be involved in the study, upload documentation verifying qualifications.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
  




HM20018316
View: SF2 - Study Funding
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Study Funding
1. * Have you applied for funding:
  Yes
No
2. Is this study already funded:
  Yes
No
 


HM20018316
View: SF2 - Types of Sites
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Types of Sites
VCU Site Information
1. * Select all VCU sites that will be utilized in this study:

Children's Hospital of Richmond at VCU

Clinical Research Services Unit (CRSU)

Massey Cancer Center

VCU Health Community Memorial Hospital

VCU Health Tappahannock Hospital

VCU Medical Center

Other VCU Health Location

VCU Monroe Park Campus

VCU Qatar

Other VCU Site
 
Non-VCU Site Information 
Non-VCU sites should be selected whenever any of the following situations apply:
   a) Non-VCU sites that will be collaborating  on a VCU-led study (i.e. involved in conducting the research,
including being involved in the study interpretation or analysis of data and/or authorship of presentations or
manuscripts related to the research.)  
   b) Non-VCU sites that will be deferring to the VCU IRB for IRB review
   c) Non-VCU sites where VCU investigators will be overseeing study interventions or interactions
   d) Non-VCU sites/locations where VCU investigators will conduct study activities
2. * Select any of the following non-VCU sites utilized in this study:

McGuire VAMC

Foreign Sites

Other Non-VCU Sites

No Non-VCU Sites
3. * Is this a multi-center study being led by VCU?
  Yes No
4. For Non-VCU Sites: For each site or institution listed as "Site Engaged -- Requests to Rely on VCU IRB
Review," upload:
- Completed Local Context Form for Relying on VCU's IRB
- Site specific informed consent form(s)  and HIPAA authorization(s), if applicable
For Foreign Sites: For each Cultural Consultant upload a CV/Biosketch that includes a clear description of
cultural expertise:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022 Elizabeth
CV/Biosketch
Yes


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
11:45 AM
Kleefisch
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
 
 


HM20018316
View: SF2 - Personnel
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Personnel
1. * List all VCU/VCUHS personnel who are key study personnel.
Key personnel are defined as including:
     - Conflict of interest investigators, including
     - the PI
     - the Lead Student/Trainee Investigator,
     - medically/Psychologically responsible investigator(s)
     - FDA Form 1572 investigators, and
     - Other personnel whose roles are essential to the conduct of the research.
Note: Individuals who are not key personnel are not required to be listed here, but PIs still bear the
responsibility to document the delegation of responsibilities in the study records.
PIs may elect to use the Study Roster activity button in RAMS-IRB (available after approval) as an alternative
way to document study staff involvement and delegation of responsibilities. Personnel changes made to the
non-key personnel listed in the separate Study Roster activity do not require an amendment.
 
Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
View Elizabeth
Bortell
Principal
Investigator
 
Data Analysis
Project
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
Clinical Services
Data Collection -
Interviews/Surveys
 
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
 
yes
View Caroline
Carrico
Co/Sub-
Investigator
 
Data Analysis
Project
Coordination
Data Management
Data Entry
Study Design
Data Coding
 
Experience -
Research
Experience -
Clinical
Education
and/or
Professional
Preparation
 
no
View Jeannette
Kierce
Co/Sub-
Investigator
 
Data Analysis
Project
 
Experience -
Research
 
no


 
Name
Roles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
Coordination
Data Collection -
Direct Observation
Participant
Consent
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
Clinical Services
Data Collection -
Interviews/Surveys
Experience -
Clinical
Education
and/or
Professional
Preparation
View Elizabeth
Kleefisch
Lead
Student/Trainee
Investigator
(leading their
own project)
 
Data Collection -
Direct Observation
Participant
Consent
Data Management
Data Collection -
Clinical
Participant
Identification
Data Entry
Study Design
Data Coding
Participant
Recruitment
Clinical Services
Data Collection -
Interviews/Surveys
 
Experience -
Research
Experience -
Related Skills
Experience -
Clinical
Education
and/or
Professional
Preparation
Trainee
 
yes
2. Identify all independent investigators and key personnel at non-VCU sites who will be engaged in this study
AND who DO NOT have IRB approval for this study from their own institution.
 NameRoles
Roles
-
Other
ResponsibilitiesResponsibilities
- Other
QualificationsQualifications
- Other
COI
Investigator
There are no items to display
3. If independent investigators or community engaged investigators are listed above,describe the human subjects
training these individuals will complete and the process that will be used to ensure that all persons assisting
with the research are adequately informed about the protocol and their research related duties and functions: 
Team calibration meeting will take before start of study via zoom meeting software with review of written protocols for
study. Throughout study communication will be completed through secure VCU email. Periodic meetings will be
completed throughout study for review of data and data analysis minimally once per quarter.
4. * Upload a CV or Biosketch for the PI, Medically/Psychologically Responsible Investigators and the lead
Student/Trainee Investigators. Do not upload CVs or Biosketches for other individuals.


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
  


HM20018316
View: SF2 - Conflict of Interest
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Conflict of Interest
The PI should ask the questions on this page of all research personnel who are engaged in the research, including
subrecipient investigators and personnel. 
1. * To the best of your knowledge, do you (as PI) or any other engaged individual have a financial interest
related to this study?
Financial interest include utilizing your licensed intellectual property in the study; serving as a paid
consultant, or advisory board member, or officer/director with a related entity; and equity or business
ownership in a company that is related to this project
  Yes No
2. * To the best of your knowledge, do you (as PI) or any other engaged individual have a non-financial interest
related to this study?
Non-financial Interests could include such things as:
- utilizing your unlicensed intellectual property in the study,
- serving as an unpaid advisory board member or officer/director with a related entity, and
- equity or business ownership in a company that has yet to make a profit and is related to this project
- conflict of time/effort,
- personal and professional relationships/affiliations,
- intellectual passions or personal beliefs
- other factors that could create bias in the study
  Yes No
3. Describe any institutional conflict of interest that you or any member of the research team are aware of that
pertains to this research:
 An institutional conflict of interest is a situation in which financial interests of the University or University
leadership may affect research activities at VCU.
  


HM20018316
View: SF2 - Other VCU Requirementsv2
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Other VCU Requirements
This page asks questions on behalf of other ancillary offices, committees and departments at VCU regarding
institutional requirements that could apply to this research. In some cases, these requirements could also
impact the consent process or other aspects of the IRB's review.
Based upon answers provided earlier in this form, certain ancillary sections below may not have questions
displayed if those requirements are not applicable to this study.
1. Cost Coverage Analysis
         Information on coverage analysis requirements and processes can be found through VCU’s Clinical
Research Compliance Program at https://research.vcu.edu/human-research/clinical-research/vcu-clinical-research-
coverage-analysis/ 
 
1. * VCU requires that all clinical research studies be evaluated to determine if a Coverage Analysis is
required. Has your study been evaluated by an institutionally designated Coverage Analysis Specialist?
Yes
No
Not Applicable
 
2. ClinicalTrials.gov Program & OnCore
For guidance, see https://cctr.vcu.edu/support/consultation/clinical-trials-gov/ or email CCTRCTGOV@vcu.edu
1. * Is this a Clinical Trial?
  Yes No 
2. * ThePI acknowledges awareness of the following requirements for posting clinical trial consent forms:
 
  - Each clinical trial under the 2018 Common Rule that is conducted or supported by a Federal
department or agency must post one IRB-approved consent form that was used to enroll subjects on a
publicly available Federal website [45 CFR 46.116(h)].
  - When engaged in multi-site research, the VCU PI is responsible for confirming with the lead site who
is responsible for posting the informed consent form.
  - When VCU is the lead site, the VCU PI is responsible for posting the informed consent form (unless
the federal department or agency will post it).
  Yes No 
3. Community Engagement
For more information, see https://community.vcu.edu/
1. * Is this a community engaged research study? (See help text for definitions)
  Yes
No
 
4. Family Educational Rights and Privacy Act (FERPA) Requirements
For guidance, see  https://rar.vcu.edu/records/family-educational-rights-and-privacy-act/
1. * Does this study involve obtaining information from VCU students' educational records (see help
text)?
  Yes
No


5. Research Data Privacy Requirements
Contact the VCU Research Data Privacy Office with questions: https://research.vcu.edu/integrity-and-
compliance/compliance/research-data-privacy/
1. * Does this study involve the VCU site (regardless of the IRB of record), or any sites under the VCU
IRB'’s oversight, obtaining data in, or from, a foreign country? 
  Yes No   
 
6. Information Security
For guidance, see https://ts.vcu.edu/askit/essential-computing/information-security/
1. * Using the VCU Data Classification Tool, please determine the appropriate data classification category
for the data that will be collected or used in this research.
Note: if the data falls into Category 1, a data security management plan is required by University
Information Security Office.
See help text for information on accessing the VCU Data Classification Tool, and for information on
creating a data security management plan at https://dms.vcu.edu.
Category 1: all data that require breach notifications in the event of improper release, including
personally identifiable information covered by HIPAA and Commonwealth of Virginia regulations.
Category 2: all proprietary data that if improperly released has the potential to cause harm to the
institution, its mission or its reputation that do not require breach notifications.
2. * I confirm use of the VCU Data Classification Tool at https://go.vcu.edu/dataclassification in determining
the data classification category selected in Question 1:
  Yes
No
3. * The PI is aware that if the study’s data is classified as Category 1, a Data Management Plan must be
submitted to and approved by VCU Information Security prior to IRB approval. See
https://ts.vcu.edu/askit/essential-computing/information-security/data-management-system/
  Yes No  
 
4. * I confirm that any use of external technology has been submitted to Information Security in the
study’s Data Management Plan. If this study uses any technology platforms, apps, services, etc. that
are maintained external to VCU or hosted by another institution and are NOT currently listed in the DMS
system as an approved service for the storage, processing, or transmission of VCU data, I am required
to have VCU Information Security conduct a security review of that technology. I may contact
infosec@vcu.edu with questions.
I also confirm that if the study involves use of external technology and VCUHS HIPAA data, I must also
seek security review from the VCUHS Data Governance group (contact Mary Harmon at
mary.harmon@vcuhealth.org):
Yes
No
N/A - not using external technology
7. Massey Cancer Center Protocol Review and Monitoring Committee (PRMC)
For guidance, see https://www.masseycancercenter.org/research/~/link.aspx?
_id=ee49e95faa8b44d09b6e89d8e3b48b57&_z=z
1. * Does this study involve any of the following?
- Research involving patients with cancer, their families or their health care providers
- Research involving cancer screening, diagnosis or prevention
- Secondary data collected from cancer patients or their medical records
- Cancer-related surveys (e.g., attitudes about risk, prevention and treatment) of the general population
  Yes
No


8. VCU ONETRAC Protocol Review Oversight Committees (PROCs) For guidance, see https://onetrac.vcu.edu/
1. * Does this study involve research with any of the following?
- VCU Health System patients
- VCU Health System facilities
- VCU Health System data   Yes
No
 
 If Yes, upload documentation of approval or review by the PROC or PRMC in this study’s topic area. If
you do not have PROC or PRMC approval, please visit onetrac.vcu.edu for additional information and
to submit your project for review.
 
9. VCU Health Department of Patient Centered Services
 
1. * Does your study involve a satisfaction survey  administered to VCUHS patients (*See Help Text):
Yes
No
Not Applicable
10. VCU Faculty-Held IND or IDE
For guidance, see https://research.vcu.edu/human-research/regulatory-affairs/.
Questions related to if you need an IND or IDE for your study should be emailed to: indide@vcu.edu. Please submit a
copy of your FDA 
submission prior to submitting to the FDA to https://redcap.vcu.edu/surveys/?s=NR7K7LR4JW.
11. VCU Health System locations
1. * Will research activities occur in patient care areas of the VCU Health System (including at CHoR,
Community Memorial Hospital, Tappahannock Hospital, VCU Medical Center and Massey Cancer
Center)?
  Yes
No
2. * The PI has reviewed and agreed to comply with the  VCU Health System Research in Patient Care
Areas policy (https://research.vcu.edu/compliance_program/vcuhs_policies.htm):
  Yes
No
12. VCUHS Department of Pathology
Learn more about requesting and establishing an account with Pathology here:  See
https://pathology.vcu.edu/research-services/
1. * I have contacted VCUHS Department of Pathology to determine feasibility if my study involves the
following: 
- Storage of Microbiology isolates
- New instrumentation provided by clinical trial/study sponsor, or 
- Non-routine specimen processing (examples include but aren’t limited to the following: addition of
reagents to samples/aliquots, buffy coat processing, DNA sample processing)
Yes
No
N/A - my study does not involve any of the listed processes.
2. * If my study involves specimen retrieval from the Pathology laboratory, I have established a process
with Pathology to deidentify and retrieve specimens.
Yes


No
N/A - my study won't involve specimen retrieval from Pathology
 
 
13. VCU Institutional Biosafety Committee (IBC)
To contact the Biosafety Office see their website at:  https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/
1. * Does this project involve any of the following hazardous biological agents (“biohazardous agents”)
that have NOT been FDA approved? These may include, but are not limited to, any of the following. If
you are unsure, please contact the Biosafety Office:
       - Any functional recombinant viruses (especially viruses that may integrate into the patients’
genome).
       - Expression or administration of biological toxins.
       - Live pathogenic or potentially pathogenic organisms of plants or animals (bacteria, fungi, wild-
type viruses, parasites, etc.), that are, or potentially may be, in experimental products.
       - Introduction or expression of rDNA or synthetic nucleic acids
       - Use of a product (e.g., monoclonal antibodies, recombinant cytokines) produced from virally
infected mammalian cells.
       - Use of a product (purified growth factors, cytokines) produced from mammals or their cells.
  Yes No
 
 
14. VCU Radiation Safety Committee (RSC)
To contact the Radiation Safety Section see their website at: https://research.vcu.edu/integrity-and-
compliance/compliance/regulatory-committees/ 
1. * Does this study involve radiation exposure and/or scans involving radiation (e.g.: PET, MRA, CT, DXA,
nuclear medicine, etc.)?
  Yes
No
           
15. VCU Scientific Review Committee (SRC)
For guidance, see https://cctr.vcu.edu/support/consultation/scientific-review-committee/
1. * Has this human subjects protocol (not the grant application) already been reviewed by the funder of a
sponsored project (e.g. a federal, state or non-profit funding sponsor)?
  Yes
No
16. Upload any documents requested in the questions above:
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
Op
Instructions.docx
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
 
 


HM20018316
View: SF2 - HIPAA
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
HIPAA
In order for VCUHS to meet HIPAA regulations regarding accounting of disclosures, data retention, and data destruction
requirements for PHI data obtained without patient authorization, members of the study team (including principal investigators)
are directed to consult with VCU Informatics to obtain any VCUHS data. This does not include obtaining data for which the
study team has patient authorization. [VCU Health System Authority and Affiliates Policy COMP-014] 
For data requests, including preparatory to research and research with decedents, submit a request for the desired PHI, or for
a consultation on alternate methods to obtain the data, at https://informatics.vcu.edu.
HIPAA Privacy Board Requirements
       For guidance, see https://www.vcuhealth.org/our-story/who-we-are/compliance-services/compliance-services
1. * Select the source of the Individually Identifiable Health Information. See help text for definitions.

PHI associated with or derived from (i.e. obtained from or entered into) VCU Health medical records or
VCU Dental Care records

Research Health Information (RHI) created or received by a study and kept solely in study records (e.g.
self reported or the result of research tests and not entered into health records)

PHI associated with or derived from (i.e. obtained from or entered into) a non-VCU HIPAA covered entity’s health
records
2. * Summarize the types of health information that will be obtained or used in this research. Do not describe
only the identifiers that you will collect or use during the study.
As part of the study patient anesthesia record, and patient dental record will be reviewed and used in this research.
3. * Describe the source(s) of the protected health information (e.g. Informatics or which clinical databases):
Patient charts in VCU Cerner and VCU Dental Axium.
4. * Does the PI certify that this study's access to and use of the protected health information is limited to the
minimum amount necessary to be able to effectively conduct the research?
  Yes No 
5. * Select all pathways this research will employ to use or access PHI  (selections will branch):

De-Identified Data (none of the 18 identifiers are recorded or associated with the research data)

Limited Data Set

Waiver of Authorization

Partial Waiver of Authorization (temporary waiver for recruitment purposes and/or waiver of some elements of
Authorization)

Signed Authorization Combined with Consent Form

Signed Authorization as Stand-Alone Form
 
  




HM20018316
View: SF2 - Documents
ID: HM20018316
HM20018316 - Elizabeth Bortell
The Effect of Local Anesthesia when used in Dental Restorative Cases Under General Anesthesia on Postoperative Comfort
  
Documents
1. Upload any documents that the VCU IRB will need to conduct a review of this submission:
A list of potential documents is given in the help text.
NOTE: The delete function should only be used if an incorrect document is uploaded or added to the system AND that
document has not been reviewed and approved by the IRB. Do NOT delete documents that the IRB previously
reviewed and approved.
Once you have uploaded a document to RAMS-IRB, any changes to that document (i.e. different versions of
the same document) should be added to the IRB submission by using the Update button. To provide updated
documents, follow these steps:
  - Click the Update button located to the left of the document to be updated.
  - In the Add Document window, click the Choose File or Browse button, select the file you are adding, and
click on the Open button.
  - Click OK to close the Add Document window, and the system will upload the revised document. RAMS-IRB
will automatically provide a version number for the document.
To access previous versions of a document in RAMS-IRB you must use the History link associated with the
document.
- Click the View or Update button located to the left of the document you wish to access.
- In the Add/View Document window, click the "History" hyperlink located to the right of the file name.
- A separate window will open that shows all versions of the document that have been added to RAMS-IRB.
Click on any file name to download and view the document.
 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
View Consent Form
Consent 11.29.22
Clean.pdf
0.21
12/1/2022
10:30 AM
Kathryn
Skarda
Consent/Assent/Information
Sheet
Yes
View Kleefisch CV
Kleefisch CV.docx 0.01
10/28/2022
11:45 AM
Elizabeth
Kleefisch
CV/Biosketch
Yes
View Research
Presentation
Script and Flow
Sheet
Research
Presentation
Flow- FINAL.docx
0.04
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Research
Consent
Presentation
and Flow Sheet
Research
Consent Flow
Sheet -
FINAL.docx
0.03
8/16/2020
6:50 PM
Kathryn
Skarda
Research Protocol
Yes
View Anesthesia
Data Collection
as part of Data
Collection
Packet
Anesthesia flow
chart.docx
0.01
7/22/2020
12:04 PM
Kathryn
Skarda
Research Measure
Yes
View Data collection
packet
Research Data
Packet .docx
0.01
7/22/2020
12:02 PM
Kathryn
Skarda
Research Measure
Yes
View FDA Lidocaine Lidocaine - Dental
FDA.pdf
0.01
5/13/2020
4:20 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
View IND Exemption
for Lidocaine
IND Exemption for
Lidocaine.docx
0.01
4/17/2020
10:03 AM
Kathryn
Skarda
Drug/Device Brochure
Yes
View Bortell CV
Bortell CV.pdf
0.01
2/18/2020
12:28 PM
Kathryn
Skarda
CV/Biosketch
Yes
View GA Post- Op
Instructions
General
Anesthesia Post-
0.01
12/17/2019
2:00 PM
Kathryn
Skarda
Other
Not
Applicable


 
Document
Name
Document
VersionDate
Modified
Uploaded
By
Type
Approved
Op
Instructions.docx
View FLACC
Behavior Scale
FLACC Behavior
Scale.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View Parent's Post
Operative Pain
Measure
Parents Post
Operative Pain
Measure.docx
0.01
12/17/2019
12:03 PM
Kathryn
Skarda
Research Measure
Yes
View MSDS
Lidocaine
MSDS.pdf
0.01
12/4/2019
1:14 PM
Kathryn
Skarda
Drug/Device Brochure
Not
Applicable
 




HM20018316
View: Bio-Medical Project Drugs
ID: HM20018316
  
Bio-Medical Project Drugs
1. * Drug:
2% Lidocaine with 1:100,000 epinephrine
2. * Manufacturer:
Henry Schein
3. * Select all types that apply:
 

FDA Approved and being used as approved

Marketed Drug/Biologic Exempt from IND

Investigational Drug/Biologic/Supplement used as drug

Supplement

Over the Counter Medication

Other (Drug or Compound Not Listed Above)
4. * Will the doses of drug administered and the dosing schedule match FDA approved labeling: (if not, include
all doses and dosing schedules in the Methods)
 
Yes
No
Not Applicable
5. * Select who holds the Investigational New Drug (IND) application for the drug/biologic:
 
External to VCU Sponsor or Investigator
VCU Sponsor-Investigator
VCU Sponsor who is not the Investigator
Not Required
6. Indicate the drug's IND number, if applicable. If the drug qualifies for IND exemption, enter "IND Exempt":
IND Exempt
  


HM20018316
View: SF_IRB_ConsentPlan_Groups
ID: HM20018316
  
Consent Groups
1. * Enter a descriptive name for this consent / assent group:
Parent/ Guardian Consent
2. * Select all that apply to this consent / assent group:
 
Name

Signed Consent by Participant

Signed Parent/Guardian Permission or Legally Authorized Representative Consent

Signed Assent by Child or Decisionally Impaired Adult

Verbal/Other Indication of Assent by Child or Decisionally Impaired Adult

Short Form Consent (limited applicability)

None of the Above (select waiver below)
3. * Select all electronic signature platforms that apply to this consent / assent group:

Not using electronic signature platforms

DocuSign Part 11 (FDA regulated studies)

DocuSign (standard platform for non-FDA regulated studies)

REDCap e-Consent

iMedConsent (Veterans Affairs studies)

Other electronic signature platform
4. If Other is selected, explain:
5. * Select any waivers that apply to this consent / assent group:
 

No Waivers Requested

Waiver of All Consent or Some Elements in Consent Form

Waiver of Parental Permission or Legally Authorized Representative Consent

Waiver of All Assent by Child or Decisionally Impaired Adult

Waiver of Signature on Consent/Permission Forms (waiver of documentation of consent)

Exception from Informed Consent (for emergency research only)
6. * Select all study team role(s) that will obtain consent / assent from this group:
 

Principal Investigator


 

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other

N/A: Requesting Waiver of Consent
7. * Describe the consent procedures used for this group. Address each point below:
        - When and where consent will occur
        - What will be covered during the consent discussion 
        - How the consent discussion will occur (e.g. in-person, phone, video conference)
        - How you will reconfirm consent on an ongoing basis, if applicable
Parents will be initially presented with the option to be considered to participate in the study at the end of their
consultation for surgery visit. Parents will be provided with a copy of the consent form on that date. Parents will be
asked to sign consent day of surgery preoperatively
8. * Select the processes for minimizing any potential perception of undue influence to participate, particularly
when there is a pre-existing relationship between the participant and the researcher (e.g. treatment
provider/patient; instructor/student; supervisor/employee, etc.):

Having a 3rd person (family/friends, another study team member, etc.) present during the consent / assent
discussion

Having an independent advocate (e.g. advocate for decisionally impaired adults, wards) present during the
consent / assent discussion

Removing physical symbols of authority like white coats or police badges

Sitting down beside the participant instead of standing over them

If obtaining consent / assent in a clinical setting, letting patients sit instead of lie down (if they are able to)

Moving to a more neutral location like a conference room

Obtaining consent / assent after other services/interactions have been completed (e.g. after school or the clinic
visit)

Having a mandatory wait period for the participant to go home and think before they sign consent /assent

Sharing the consent / assent discussion between two people (i.e. a clinician might be the best person to explain
study procedures and risks, but then they could step out and let a research assistant finish the consent process)

Other protection(s) not listed here – describe below



N/A: Requesting Waiver of Consent
9. * Describe the other ways the study team will minimize any potential perception of undue influence to
participate:
All parents of patients will be given the consent forms at the day of their consultation and be given the opportunity to
think about whether they would wish to participate at home with their family. Consent will be performed by a separate
nurse day of surgery after consent for dental treatment under general anesthesia by the dental surgery team on that
date. Families will be informed that their decision will not alter the dental care that will be rendered whether they
choose to proceed or not. To help to minimize coercion we are having a separate nurse obtain consent after all other
consents have already been obtained.
10. * How much time will participants be given to make a decision:
Parents of patients will be asked to participate in the study at the close of their consultation for surgery. Parents of
patients will have the time from the date of consultation to the day of surgery to decide if they would like to participate
in the study.
11. If applicable, describe the procedures for consenting children upon entering adulthood or participants who
are no longer decisionally impaired:
 


HM20018316
View: Personnel
ID: HM20018316
  
Personnel
1. * Name:
Elizabeth Bortell
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab


 

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:


 


HM20018316
View: Personnel
ID: HM20018316
  
Personnel
1. * Name:
Caroline Carrico
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab


 

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Individual has no clinical responsibilities
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:


 


HM20018316
View: Personnel
ID: HM20018316
  
Personnel
1. * Name:
Jeannette Kierce
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab


 

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:


 


HM20018316
View: Personnel
ID: HM20018316
  
Personnel
1. * Name:
Elizabeth Kleefisch
2. * Is this individual a 'COI Investigator'?
Conflict of Interest (COI) Investigator - any individual who has a level of independence and responsibility
comparable to that of the PI for the design, conduct, or reporting of research.
Anyone designated as a COI Investigator must have a current Financial Interest Report (FIR) in the Activity and
Interest Reporting System (AIRS) (https://airs.research.vcu.edu).
  Yes
No
3. * Roles:
 

Principal Investigator

Co/Sub-Investigator

Medical or Psychological Responsible Investigator

Lead Student/Trainee Investigator (leading their own project)

Research Coordinator

Research Nurse

Consultant

Research Assistant

Pharmacist

Statistician

Regulatory Coordinator

Trainee/Student(working on project)

Other
4. * Study related responsibilities:
 

Study Design

Data Collection - Lab


 

Data Collection - Clinical

Data Collection - Interviews/Surveys

Data Collection - Direct Observation

Clinical Services

Intervention Services

Data Entry

Data Coding

Data Management

Data Analysis

Project Coordination

Participant Identification

Participant Recruitment

Participant Consent

Regulatory Management

Other
5. * The PI certifies that if this individual will conduct any clinical activities as part of this study, the individual is
appropriately credentialed and privileged to practice within the institution where the research will be
conducted:
Yes
6. * Qualifications to carry out study related responsibilities: (you may select multiple answers)
 

Education and/or Professional Preparation

Experience - Research

Experience - Clinical

Experience - Related Skills

Trainee

Student

Other
7. Additional or Emergency Phone:


 


HM20018316
View: SF_IRB_Summary_Document
ID: HM20018316
Add Document
1. * Document Name:
Consent Form
2. * Type:
Consent/Assent/Information Sheet
3. * File:

Consent 11.29.22 Clean.pdf(0.21)












HM20018316
View: SF_IRB_Summary_Document
ID: HM20018316
Add Document
1. * Document Name:
FDA Lidocaine
2. * Type:
Drug/Device Brochure
3. * File:

Lidocaine - Dental FDA.pdf(0.01)




HM20018316
View: SF_IRB_Summary_Document
ID: HM20018316
Add Document
1. * Document Name:
Bortell CV
2. * Type:
CV/Biosketch
3. * File:

Bortell CV.pdf(0.01)








HM20018316
View: SF_IRB_Summary_Document
ID: HM20018316
Add Document
1. * Document Name:
MSDS Lidocaine
2. * Type:
Drug/Device Brochure
3. * File:

MSDS.pdf(0.01)

ICF_002.pdf: 
1
RESEARCH PARTICIPANT INFORMATION AND CONSENT FORM
STUDY TITLE: The Effect of Local Anesthesia when used in Dental Restorative Cases 
Under General Anesthesia on Post-Operative Comfort 
VCU INVESTIGATORS: Dr. Elizabeth Bortell (PI)
 Dr. Jeanette Kierce (co-I)
[NOTE: In this consent form, if you are a parent or legal guardian, please remember that 
“you” refers to the child study participant.]
ABOUT THIS CONSENT FORM
You are being invited to participate in a research study. It is important that you carefully 
think about whether being in this study is right for you or your child and your situation.
This consent form is meant to assist you in thinking about whether or not you want to be in 
this study. Please ask the study doctor or the study staff to explain any information in this 
consent document that is not clear to you. You may take home an unsigned copy of this 
consent form to think about or discuss with family or friends before making your decision.
Your participation is voluntary. You may decide to not participate in this study. If you do 
participate, you may withdraw from the study at any time. Your decision not to take part or 
to withdraw will involve no penalty or loss of benefits to which you are otherwise entitled.
AN OVERVIEW OF THE STUDY AND KEY INFORMATION
Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental 
office. This is usually accomplished by administering a shot of numbing medicine (local 
anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for 
care in the dental office however despite its standardized use in dental clinics use of local 
anesthetic is not standardized for use in dental cases under GA. In the literature there is 
some evidence suggesting  that it has some marginal benefit for pain control short term post 
operatively.
You are being asked to participate in this study because you have been diagnosed with 
diseases of tooth/teeth and have consented to its treatment that requires treatment under 
general anesthesia .
The purpose of this study is to compare patient responses after surgery when local anesthetic is 
used for dental treatment under GA and when it is not used.
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The study section will have 60 participants of which one half will receive local anesthesia for 
restorative dental care under GA and the other half will receive conventional no anesthesia 
for restorative dental treatment under GA, based on random assignment (like the flip of a 
coin). You have an equal chance of being assigned to either group prior to the consented 
treatment. Before the surgery, a nurse will assess your child’s overall pain and comfort. The 
study team (faculty, anesthesiologist, and resident) will record the blood pressure, heart 
rate, and breathing duration throughout the procedure. After the child has completed the 
surgery a nurse will again access your child’s overall pain and comfort. Lastly, you will be 
contacted that evening of surgery by a member of the study team to check up on your child 
and will be asked some questions to assess your child’s comfort at home.  
Your participation in this study will occur on the day of your child’s surgery and will last 
until time of discharge. Approximately 60 participants will take part in the study.
Please read, or have someone read to you, the rest of this document. If there is anything 
you don’t understand, be sure to ask the study staff.
WHY IS THIS STUDY BEING DONE?
Use of local anesthesia for dental restorative work under General Anesthesia is not 
standardized among providers. 
The purpose of this study is to:
1. Evaluate patient pain, irritability and discomfort post operatively after 
surgery in patients when local anesthetic is used to when it is not used intra 
operatively during the surgery.
With this study we seek to determine if local anesthetic is a beneficial tool for use In 
dental cases under general anesthetic to standardize practices among dental providers. 
WHAT WILL HAPPEN IF I PARTICIPATE IN THE STUDY?
If you are interested in this study, a member of the study team will go over the study in 
detail and obtain your informed consent. You will have ONE research related study visit 
during which you will:
1. Pre-operatively a Nurse will assess your child’s comfort before surgery and 
give it a score. 
2. Patients will be taken back for surgery to the operating room and 
have their dental work completed with or without local anesthetic 
(based on random assignment). 
3. Post-operatively a Nurse will assess your child’s comfort after 
surgery and give it a score.
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4. That evening following surgery you will be contacted to check up on 
your child after surgery and over the phone you will be asked some 
questions to assess your child’s comfort at home.
WHAT ALTERNATIVE TREATMENTS OR PROCEDURES ARE AVAILABLE?
If you decide not to enter this study, you will receive the General Anesthesia and 
local anesthesia will be administered at the digression of the dentist providing 
care day of surgery.
WHAT ARE THE BENEFITS OF BEING IN THE STUDY?
Local anesthesia is standardly used for dental care in the dental office. Local anesthesia 
use in the operating room is less standardized and is used based upon provider 
preference. There is some evidence that local anesthesia can help with post-operative 
pain. However, local anesthesia is also seen to have an increase in lip biting due to lack of 
sensation and discomfort to patients due to altered sensation. Effects of local anesthesia 
have a short duration and sensation quickly returns after surgery. Every patient's response 
is different and we hope to track that response to help the study doctors learn things that 
may help other people in the future.
WHAT RISKS AND DISCOMFORTS COULD I EXPERIENCE FROM BEING IN THE STUDY?
Possible Risks Associated with 2% Lidocaine local anesthetic use :
Occasional: (Between 1-10% chance that this will happen)
●
Headache
●
Swelling 
●
Infection
●
Nausea
●
Inflammation of the gums
Rare:
●
Earache
●
Numbness and tingling
●
Difficulty opening the mouth
●
Allergic reaction
●
Systemic toxicity 
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Non-Physical Risks
Participation in research might involve some loss of privacy and confidentiality. There is a 
small risk that someone outside the research study could see and misuse information about 
you.
WHAT ARE THE COSTS?
You and your insurance plan will pay for the costs of dental care you get as part of the 
study, just as you would if you were getting the usual care for your condition. 
WILL I BE PAID TO PARTICIPATE IN THE STUDY?
No.
WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN 
THE STUDY?
If you are injured by, or become ill, from participating in this study, please contact your study 
doctor immediately. Medical treatment is available at the Virginia Commonwealth 
University Health System (VCU Health System). Your study doctor will arrange for short-term 
emergency care at the VCU Health System or for a referral if it is needed.
Fees for such treatment may be billed to you or to appropriate third party insurance. Your 
health insurance company may or may not pay for treatment of injuries or illness as a result 
of your participation in this study. To help avoid research-related injury or illness, it is very 
important to follow all study directions.
CAN I STOP BEING IN THE STUDY?
Your participation in the study would be restricted to one study visit. You will have a 
choice to withdraw from the study before the start of the procedure during study 
visit. Since all research data is collected on this visit, you will not be able withdraw 
from the study after this visit is complete. Data that has already been collected 
about you will remain part of the study database and may not be removed.
Your participation in this study may be stopped at any time by the study doctor without 
your consent. The reasons might include:
●
the study doctor thinks it is necessary for your health or safety
●
you are found to not be eligible for the study
●
the sponsor of the study drug has stopped the support for the study
●
administrative reasons require your withdrawal
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●
the anesthesiologist chooses to administer Precedex or Ketolorac for pain 
management during the dental procedure under general anesthesia for post-
operative pain management 
HOW WILL INFORMATION ABOUT ME BE PROTECTED?
VCU and the VCU Health System have established secure research databases and 
computer systems to store information and to help with monitoring and oversight of 
research. Your information may be kept in these databases but are only accessible to 
individuals working on this study or authorized individuals who have access for specific 
research related tasks.
Identifiable information in these databases are not released outside VCU unless stated in 
this consent or required by law. Although results of this research may be presented at 
meetings or in publications, identifiable personal information about participants will not be 
disclosed.
Personal information about you might be shared with or copied by authorized 
representatives from the following organizations for the purposes of managing, monitoring 
and overseeing this study:
●
Representatives of VCU and the VCU Health System
●
Officials of the Department of Health and Human Services or the Federal 
Food and Drug Administration
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as 
required by U.S. Law. This Web site will not include information that can identify you. At 
most, the Website will include a summary of the results. You can search this Web site at 
any time.
There are no plans to use the information gathered in this research study for any 
commercial profit.
In general, we will not give you any individual results from the study. If we find something of 
medical importance to you, we will inform you, although we expect that this will be a very 
rare occurrence. Once the study has been completed, we will send you a summary of all of 
the results of the study and what they mean.
FUTURE RESEARCH STUDIES
The information collected as part of this study will not be used or distributed for 
future research studies, even if identifiers are removed.
V
C
U 
IR
B 
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HOW WILL MY HEALTH INFORMATION BE USED AND SHARED DURING THIS STUDY?
As part of this research study, we will ask you to share identifiable health information with 
us and/or permit us to access existing information from your healthcare records. New 
health information may also be created from study-related tests, procedures, visits, and/or 
questionnaires. This type of information is considered “Protected Health Information” that 
is protected by federal law.
VCU and the VCU Health System have established secure research databases and 
computer systems to store information and to help with monitoring and oversight of 
research. Your information may be kept in these databases but are only accessible to 
individuals working on this study or authorized individuals who have access for specific 
research related tasks.
Identifiable information in these databases are not released outside VCU unless stated in 
this consent or required by law. Although results of this research may be presented at 
meetings or in publications, identifiable personal information about participants will not be 
disclosed.
Who will use or share protected health information about me?
VCU and VCU Health are required by law to protect your identifiable health information. 
By consenting to this study, you authorize VCU/VCU Health to use and/or share your 
health information for this research. The health information listed above may be used by 
and/or shared with the following people and groups to conduct, monitor, and oversee the 
research:
●
Principal Investigator and Research Staff
●
Health Care Providers at VCU Health
●
Data Coordinators
●
Institutional Review Boards
●
Data Safety Monitoring Boards
●
Government/Health Agencies
●
Others as Required by Law
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Once your health information has been disclosed to anyone outside of this study, 
the information may no longer be protected under this authorization.
When will this authorization (permission) to use my protected health information expire?
This authorization will expire when the research study is closed, or there is no need to 
review, analyze and consider the data generated by the research project, whichever is 
later.
STATEMENT OF PRIVACY RIGHTS
You may change your mind and revoke (take back) the right to use your protected health 
information at any time. However, even if you revoke this authorization, the researchers 
may still use or disclose health information they have already collected about you for this 
study. If you revoke this Authorization you may no longer be allowed to participate in the 
research study. To revoke this Authorization, you must write to the Principal Investigator.
WHO SHOULD I CONTACT IF I HAVE QUESTIONS ABOUT THE STUDY?
If you have any questions, complaints, or concerns about your participation in this 
research, contact:
Principal Investigator:
1. Dr. Elizabeth Bortell, DDS.
Director of Pediatric Dentistry 
Services Brook Rd Campus, 
Associate Professor 
305, Wood Building, VCU 
School of Dentistry 521 N 11th 
St, Richmond, VA 23298
Ph: (804) 228- 5895
Co-Investigators:
1. Dr. Jeanette Kierce, MD DABA FAAP
Pediatric Anesthesiology
VCU Medical Center Main 
Hospital 
1250 E. Marshall St. Richmond, 
VA 23219
Ph: (804) 828-9205
The researchers/study staff named above are the best persons to call for questions about 
your participation in this study.
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If you have general questions about your rights as a participant in this or any other 
research, you may contact:
Virginia Commonwealth University 
Office of Research 800 East Leigh Street, 
Suite 3000
Box 980568
Richmond, VA 23298
Telephone: (804) 827-2157
Contact this number to ask general questions, to obtain information or offer input, and 
to express concerns or complaints about research. You may also call this number if you 
cannot reach the research team or if you wish to talk to someone else. General 
information about participation in research studies can also be found at 
http://www.research.vcu.edu/irb/volunteers.htm.
Do not sign this consent form unless you have had a chance to ask questions and have 
received satisfactory answers to all of your questions.
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STATEMENT OF CONSENT [AND/OR PARENT/LEGAL GUARDIAN PERMISSION]
I have been provided with an opportunity to read this consent form carefully. All of the 
questions that I wish to raise concerning this study have been answered. By signing this 
consent form, I have not waived any of the legal rights or benefits to which I and/or my child 
otherwise would be entitled. My signature indicates that I freely consent to participate 
[and/or give permission for my child to participate] in this research study. I will receive a copy 
of the consent form for my records.
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________________________________________________
Name of Participant (Printed)
________________________________________________
________________
Witness or Interpreter’s Signature
Date
(NOTE: The witness may be the interpreter or a family member of the LEP subject who can speak 
both English and the participant’s language.  The witness cannot be the member of the study 
team conducting the consent process.)
________________________________________________
Name of Person Conducting Consent/Assent Discussion (Printed)
________________________________________________
________________ Signature of 
Person Conducting Consent/Assent Discussion
Date
________________________________________________
________________
Principal Investigator Signature (if different from above) 
Date 
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