Clinical trial NCT06182631
Conditions: Intravenous Administration
Keywords: analgesic anxiolytic Buzzy Bee Shot-blocker
Sponsor: State University of New York at Buffalo
Start date: 2019-07-15; Completion date: 2021-01-15
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the anxiety and pain levels of patients when using Buzzy with ice, Vapocoolant, and placebo when inserting IV's line for IV fluids and/or phlebotomy in pediatric patients in the pediatric emergency department.

Detailed description:

Arms: arm 1: Will have nurse spray vapocoolant on the skin before IV insertion, will then videotape patient and ask them and parent to fill out FACES form. arm 2: Will have nurse put Buzzy Bee on arm before, and leave it on during IV insertion. Will then videotape patient and ask them and parent to fill out FACES form. arm 3: Will have nurse place a rubber band around arm before IV insertion. Will then videotape patient and ask them and parent to fill out FACES form.
Interventions: intervention 1: Buzzy Bee intervention 2: Vapocoolent intervention 3: Placebo
Intervention descriptions: intervention 1: The Buzzy is a vibrating palm-sized device with removable ice wings developed by MMJ Labs Atlanta, GA. It uses Melzack and Wall's Gait Control theorywhich asserts that activation of non-nociceptive fibers can interfere with signals from pain fibers thereby inhibiting pain. intervention 2: Vapocoolent is a volatile refrigerated liquid, ie ethyl chloride, which is supposed to feel like the skin is numb before insertion of the IV. intervention 3: A band will be placed on the arm before IV insertion for placebo effect.

Protocol documents:
Prot_SAP_000.pdf: 
 
Official Title: 
A Randomized Clinical Trial of Buzzy versus Vapocoolant 
in Pain Relief during a venipuncture procedure in a 
pediatric Emergency Room  
NCT number: 
unavailable 
Document Type: 
Study Protocol (HRP 503)  and  statistical plan 
Date of the 
Document: 
December 2, 2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Complete Research Protocol (HRP-503) 
 
Table of Contents 
Template Instructions.......................................................................................................... 3 
1.0 
Objectives ................................................................................................................ 5 
2.0 
Scientific Endpoints ................................................................................................. 5 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Design ............................................................................................................ 8 
5.0 
Local Number of Subjects ....................................................................................... 8 
6.0 
Inclusion and Exclusion Criteria .............................................................................. 8 
7.0 
Vulnerable Populations .......................................................................................... 10 
8.0 
Eligibility Screening .............................................................................................. 11 
9.0 
Recruitment Methods ............................................................................................. 11 
10.0 Procedures Involved............................................................................................... 12 
11.0 Study Timelines ..................................................................................................... 14 
12.0 Setting .................................................................................................................... 14 
13.0 Community-Based Participatory Research ............................................................ 15 
14.0 Resources and Qualifications ................................................................................. 15 
15.0 Other Approvals ..................................................................................................... 18 
16.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 18 
17.0 Data Management and Analysis ............................................................................ 18 
18.0 Confidentiality ....................................................................................................... 19 
A. 
Confidentiality of Study Data ............................................................................ 19 
B. 
Confidentiality of Study Specimens ................................................................... 21 
19.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 21 
20.0 Withdrawal of Subjects .......................................................................................... 22 
21.0 Risks to Subjects .................................................................................................... 23 
22.0 Potential Benefits to Subjects ................................................................................ 24 
23.0 Compensation for Research-Related Injury ........................................................... 24 
24.0 Economic Burden to Subjects ................................................................................ 24 
25.0 Compensation for Participation ............................................................................. 24 
26.0 Consent Process ..................................................................................................... 25 
27.0 Waiver or Alteration of Consent Process ............................................................... 29 
28.0 Process to Document Consent ............................................................................... 29 
29.0 Multi-Site Research (Multisite/Multicenter Only)................................................. 30 
30.0 Banking Data or Specimens for Future Use .......................................................... 31 
31.0 Drugs or Devices.................................................................................................... 31 
32.0 Humanitarian Use Devices .................................................................................... 32 
 
 
 


Template Instructions 
Sections that do not apply: 
 In several sections, the addition of checkboxes for Not Applicable have been added to the 
template as responses.   
o If an N/A checkbox is present, select the appropriate justification from the 
list.   
o If an N/A checkbox is not present, or if none of the existing checkboxes 
apply to your study, you must write in your own justification. 
 In addition: 
o For research where the only study procedures are records/chart review:  
Sections 19, 20, 22, 23, 24, 25, 31, and 32 do not apply. 
o For exempt research:  Sections 31 and 32 do not apply. 
 
Studies with multiple participant groups: 
 
 If this study involves multiple participant groups (e.g. parents and children), provide 
information in applicable sections for each participant group. Clearly label responses 
when they differ.  For example: 
Response:  
Intervention Group:  
Control Group: 
Formatting: 
 Do not remove template instructions or section headings when they do not apply to your 
study. 
If you are pasting information from other documents using the “Merge Formatting” Paste 
option will maintain the formatting of the response boxes. 
Amendments: 
 When making modifications or revisions to this and other documents, use the Track 
Changes function in Microsoft Word. 
 Update the version date or number on Page 3. 
 
 


PROTOCOL TITLE: 
Include the full protocol title. 
Response:  
A Randomized Clinical Trial of Buzzy versus Vapocoolant in Pain Relief during a 
venipuncture procedure in a pediatric Emergency Room  
 
PRINCIPAL INVESTIGATOR: 
Name 
Department 
Telephone Number 
Email Address 
Response:  
Name: Jill C Fennell MD 
Department Division of Emergency Medicine 
John R. Oishei Children’s Hospital 
Telephone No: 716-323-0055 
Email Address jillfenn@buffalo.edu 
 
VERSION: 
Include the version date or number. 
Response: Version 3.0 
Version date: December 2, 2020 
 
GRANT APPLICABILITY: 
Indicate whether this protocol is funded by a grant (e.g. NIH, foundation grant).  For a 
grant with multiple aims, indicate which aims are covered by this research proposal. 
NOTE: This question does not apply to studies funded by a sponsor contract. 
Include a copy of the grant proposal with your submission.     
Response:  
This study is not funded 


 
RESEARCH REPOSITORY: 
Indicate where the research files will be kept, including when the study has been closed.  
The repository should include, at minimum, copies of IRB correspondence (approval, 
determination letters) as well as signed consent documents.  This documentation should 
be maintained for 3 years after the study has been closed.   
Response:   
Location:  Conventus building, Research office, Room 5201 
Address: 1001 Main Street, Buffalo NY  
Department: UBMD Pediatrics, Division of Emergency Medicine 
1.0 Objectives 
1.1 Describe the purpose, specific aims, or objectives of this research. 
Response:  
The purpose of this study is to compare the anxiety and pain levels of patients when using 
Buzzy with ice wings, Vapocoolant, and placebo during venipuncture procedure in 
pediatric patients.  
1.2 
State the hypotheses to be tested, if applicable. 
NOTE:  A hypothesis is a specific, testable prediction about what you expect to happen in 
your study that corresponds with your above listed objectives. 
Response:  
We hypothesize that the Buzzy will provide greater pain relief based on patient self-
report and parent report of their child’s pain as well as independent observation when 
compared to Vapocoolant or placebo.   
2.0 Scientific Endpoints 
 
2.1    Describe the scientific endpoint(s), the main result or occurrence under study.   
 
NOTE:  Scientific endpoints are outcomes defined before the study begins to determine whether 
the objectives of the study have been met and to draw conclusions from the data.  Include 
primary and secondary endpoints.  Some example endpoints are:  reduction of symptoms, 
improvement in quality of life, or survival.  Your response should not be a date.   
Response:  
Our primary outcome is that Buzzy will have a greater degree of reduction of anxiety and 
pain levels compared to vapocoolant or placebo.  
3.0 Background 


3.1 Provide the scientific or scholarly background, rationale, and significance of the 
research based on the existing literature and how it will contribute to existing 
knowledge.  Describe any gaps in current knowledge.  Include relevant preliminary 
findings or prior research by the investigator.  
Response:  
Among pediatric patients, phlebotomy and intravenous cannulation are two 
important sources of self-reported pain in the pediatric ED.  Unmanaged needle 
stick pain has been associated with needle phobia, greater pain with future sticks; 
anxiety associated with other medical procedures, healthcare avoidance and 
increased adult pain sensitivity (Lunoe, 2014; Cohen 1997; Hamilton, 1995; Pate, 
1996).  Various methods have been proposed for management of acute pain 
associated with these medical procedures.  Pharmacological methods include 
EMLA, lidocaine and ethyl chloride (vapocoolant).  Behavioral methods such as 
information provision, distraction, sensory focusing, and cognitive behavioral 
therapy (CBT) have also been utilized (Blount, 2009).    Optimization of pain 
control during phlebotomy and IV catheterization in the Pediatric ED is essential 
in an effort to avoid the aforementioned adverse effects of needle insertion.  In the 
pediatric ED, quick acting methods are favored over those requiring time to act 
such as EMLA and CBT.  
Vapocoolants, volatile refrigerated liquids such as ethyl chloride, are a frequent 
choice in many pediatric EDs, including our own, prior to phlebotomy or IV 
cannulation.  Despite this, research has offered conflicting results as to their 
efficacy. Hogan and her colleagues conducted a systematic review of 
Vapocoolant in both children and adults and concluded that their “…results 
demonstrated that Vapocoolants are ineffective in children when compared to 
placebo or no treatment” (Hogan ,2014).  Shah, Taddio & Rieder have 
hypothesized that the sensation of cold on their skin is perceived by children as 
painful (Shah, 2009).      
Recently several labs have introduced hand held devices based on Melzack and 
Wall’s Gait Control theory (Melzack 1965) which asserts that activation of non-
nociceptive fibers can interfere with signals from pain fibers thereby inhibiting 
pain.  This theory helps to explain why rubbing or massaging a painful area of 
skin can lessen the pain.  One such device is the Buzzy.. The Buzzy is a vibrating 
palm-sized device with removable ice wings developed by MMJ Labs Atlanta, 
GA.   
The Procedure Behavior Checklist (PBCL) is a well-established observational pain 
measure that has been validated for children 3-18 years old.  It evaluates both the 
intensity and frequency of 10 defined behaviors that indicate distress. The PBCL was 
developed by Katz et al in 1980.  On a scale of 1-5, it rates child’s muscle tension, 
screaming, crying, restraint needed, verbalized pain, anxiety, etc.  The scores are then 
added together to give a final score.  The Faces Pain Scale – Revised (FPS- R; Hicks et al 
1990) is a self-report measure used to assess the intensity of children's pain.  It consists of 
6 faces, with each one representing an increasing degree of pain moving from left to right 
in increments of two starting from zero (0, 2, 4, 6, ,8, 10).   


Both of the PBCL and Faces pain scale –revised have been validated tool and used 
frequently in clinical practices and studies when evaluate patient’s pain scale.  
In this study, we will compare the effectiveness of pain release devices i.e. buzzy, with 
vapocoolants or placebo. We will use the validated PBCL and Faces pain scale-revised 
methods as the pain evaluation tools.  To our knowledge, no study has been performed on 
comparison of the effectiveness of these commonly used pain release devices.  We hope 
to contribute some useful information in this field through our research.  
3.2 Include complete citations or references.  
Response:   
Bijttebier P, Vertommen H. (1998). The impact of previous experience on 
children's reactions to venipunctures. Journal of Health Psychology, 3 (1):39– 46. 
Blount R. L., Zempsky W. T., Jaaniste T., Evans S., Cohen L. L., Devine K. A., 
Zeltzer L. K. Management of pain and distress due to medical procedures. In: 
Roberts M C, Steele R, editors. Handbook of pediatric psychology. 4th Ed. New 
York: Guilford Press; 2009. pp.171–188. 
Cohen Reis E. &and Holubkov R. (1997). Vapocoolant spray is equally effective 
as EMLA cream in reducing immunization pain in school-aged children.  
Pediatrics, 100 (6). 
Hamilton J.G. (1995). Needle phobia: A neglected diagnosis. Journal of Family 
Practice, 41 (2):169-175. 
Hicks C.L., von Baeyer, C.L., Spafford P.A., van Korlaar I. & Goodenough B. The 
Faces Pain Scale - Revised: toward a common metric in pediatric pain 
measurement.  Pain 93(2001) 173-183. 
Lunoe M.M, Drendel A.L., Levas M.N., Weisman S.J., Dasgupta M., Hoffman, 
R.G. & Brousseau D.C. (2015). A randomized clinical trial of jet-induced 
lidocaine to reduce venipuncture pain for young children. Annals of Emergency 
Medicine, 66 (5), 466-474. 
Melzack R. & Wall P.D. (1965). Pain mechanisms: A new theory. Science, 150: 
971-979. 
Pate J.T., Blount R.L., Cohen L.L. & Smith A.J. (1996). Childhood medical 
experience and temperament as predictors of adult functioning in medical 
situations. Child Health Care, 25 (4): 281-298. 
Shah V., Taddio A. & Rieder M.J. (2009). Effectiveness and tolerability of 
pharmacologic and combined interventions for reducing injection pain during 
routine childhood immunizations: Systematic review and meta-analyses.  Clinical 
Therapeutics, 31 
 (Supplement 2), S104-51.  
Katz, E.R., Kellerman, J., & Siegel, S.E. (1980). Behavioral distress in children 
with cancer undergoing medical procedures: Developmental considerations. 
Journal of Consulting and Clinical Psychology, 48, 356-365. 


LeBaron, S. & Zeltzer, L. (1984). Assessment of acute pain and anxiety in 
children and adolescents by self-reports, observer reports, and a behavior 
checklist. Journal of Consulting and Clinical Psychology, Vol 52, No. 5, 729-
738. 
QFAB Bioinformatics. (2015). ANZMTG Statistical Decision Tree, Power 
Calculator. (Version 1.0) [Web Application]. Retrieved from 
http://www.anzmtg.org/stats/PowerCalculator 
4.0 Study Design 
4.1 Describe and explain the study design (e.g. case-control, cross-sectional, 
ethnographic, experimental, interventional, longitudinal, observational). 
Response:  
This is a single-center, randomized, open label, placebo controlled clinical trial.    
5.0 Local Number of Subjects 
5.1 Indicate the total number of subjects that will be enrolled or records that will be 
reviewed locally. 
Response:  
We will enroll 168 patients in the study with 56 in each arm.   
5.2 If applicable, indicate how many subjects you expect to screen to reach your target 
sample (i.e. your screen failure rate).  
Response:   
We anticipate screening about 500 patients to reach our target sample.  
5.3 Justify the feasibility of recruiting the proposed number of eligible subjects within 
the anticipated recruitment period. For example, how many potential subjects do 
you have access to? What percentage of those potential subjects do you need to 
recruit? 
Response:  
The Emergency Department at John R Oishei Children’s Hospital has an annual volume 
of 45,000 to 50, 000 patients, with at least 1/10 of them receiving venipunctures 
procedure including IV’s line placement or phlebotomy procedure for various reasons.  
We anticipate that we can easily enroll 168 subjects within 24 months.   
6.0 Inclusion and Exclusion Criteria 
6.1 Describe the criteria that define who will be included in your final study sample.  
NOTE:  This may be done in bullet point fashion. 
Response:  
Inclusion criteria: 
1. Male or female patients 6 to18 years old 


2.  Need venipuncture procedure including IV’s line placement and/or phlebotomy at the 
ED. 
6.2 Describe the criteria that define who will be excluded from your final study sample.   
NOTE:  This may be done in bullet point fashion.  
Response:   
Exclusion criteria include:    
1. Patients is sensitive to cold i.e. Raynaud’s  disease. 
2. Sickle cell disease, diabetic  
3. Critically ill patients  
4. Mentally challenged patients  
5.. GCS< 15   
6.. Patient with altered sensation  
7.. Patients needing more than one attempt for IV placement or phlebotomy 
6.3 Indicate specifically whether you will include any of the following special 
populations in your study using the checkboxes below.   
 
NOTE:  Members of special populations may not be targeted for enrollment in your 
study unless you indicate this in your inclusion criteria. 
Response:   
☐ 
Adults unable to consent 
☒ 
Individuals who are not yet adults (infants, children, teenagers) 
☐ 
Pregnant women   
☐ 
Prisoners 
6.4 Indicate whether you will include non-English speaking individuals in your study.  
Provide justification if you will exclude non-English speaking individuals.  
In order to meet one of the primary ethical principles of equitable selection of 
subjects, non-English speaking individuals may not be routinely excluded from 
research as a matter of convenience. 
In cases where the research is of therapeutic intent or is designed to investigate 
areas that would necessarily require certain populations who may not speak 
English, the researcher is required to make efforts to recruit and include non-
English speaking individuals.  However, there are studies in which it would be 
reasonable to limit subjects to those who speak English.  Some examples include 
pilot studies, small unfunded studies with validated instruments not available in 
other languages, studies with numerous questionnaires, and some non-therapeutic 
studies which offer no direct benefit. 
Response:  


This study will not include patients whose legal guardians do not speak English.  
Children with parents/legal guardians who cannot speak and read English will be 
encountered infrequently.  They represent diverse language groups and translating 
consent documents as well as translating pain scale surveys into many languages would 
be impractical for this unfunded study.  Meanwhile, it is impractical for us to have two 
people who speak the same non-English language during the recruitment phase with one 
being the person who obtains the consent and one being the witness per our IRB request 
at any given time.  
By not including non-English speaking subjects in this study, we are not withholding any 
benefit from these patients. Meanwhile, we do not anticipate that we add any burden to 
the patients who are enrolled in the study.   
The main purpose of this study is to compare the effectiveness of pain relief using 
different methods, the Buzzy, vapocoolant and placebo.  Patient enrolled in the study will 
randomly assigned into one of the three different study groups, Buzzy Bee with ice 
wings, vapocoolant or placebo. For eligible patients that are not enrolled in the study,  
they may also receive buzzy, or vapocoolant intervention, depending on the bedside 
nurse’s discretion, as these methods have been frequently used by our ED nurses to help 
patients for pain relief. So regardless weather a patient is enrolled in the study or not, 
he/she may receive the similar pain relief method for IV line placement or phlebotomy 
procedure. 
Thus, we will exclude subjects whose legal guardians do not speak English from the 
study due to the above mentioned reasons.  We believe that we will not withhold any 
benefit from non-participants, nor add any burden to the participants by not enrolling 
non-English speaking patients in the study. 
7.0 Vulnerable Populations 
If the research involves special populations that are considered vulnerable, describe the 
safeguards included to protect their rights and welfare.   
NOTE: You should refer to the appropriate checklists, referenced below, to ensure you have 
provided adequate detail regarding safeguards and protections. You do not, however, need to 
provide these checklists to the IRB. 
7.1 For research that involves pregnant women, safeguards include: 
NOTE CHECKLIST: Pregnant Women (HRP-412) 
Response: 
☒ 
N/A:  This research does not involve pregnant women. 
7.2 For research that involves neonates of uncertain viability or non-viable neonates, 
safeguards include: 
NOTE CHECKLISTS: Non-Viable Neonates (HRP-413), or Neonates of Uncertain 
Viability (HRP-414) 
Response:  
☒ 
N/A:  This research does not involve non-viable neonates or neonates of uncertain 
viability. 


7.3 
For research that involves prisoners, safeguards include: 
NOTE CHECKLIST: Prisoners (HRP-415) 
Response:  
☒ 
N/A:  This research does not involve prisoners. 
7.4 For research that involves persons who have not attained the legal age for consent 
to treatments or procedures involved in the research (“children”), safeguards 
include:   
NOTE CHECKLIST: Children (HRP-416) 
Response:  
We will obtain consent from legal guardian for subject who is younger than 18 years of 
age.  
☐ 
N/A:  This research does not involve persons who have not attained the legal age 
for consent to treatments or procedures (“children”). 
7.5 For research that involves cognitively impaired adults, safeguards include: 
NOTE CHECKLIST: Cognitively Impaired Adults (HRP-417) 
Response:  
☒ 
N/A:  This research does not involve cognitively impaired adults. 
7.6 Consider if other specifically targeted populations such as students, employees of a 
specific firm, or educationally or economically disadvantaged persons are 
vulnerable.  Provide information regarding their safeguards and protections, 
including safeguards to eliminate coercion or undue influence. 
Response:   
No other specifically targeted populations will be enrolled in this project.  
8.0 Eligibility Screening  
8.1 
Describe screening procedures for determining subjects’ eligibility.  Screening 
refers to determining if prospective participants meet inclusion and exclusion criteria.  
Include all relevant screening documents with your submission (e.g. screening 
protocol, script, questionnaire).  
Response:  
We will use a screening sheet to help our physician identify patient’s eligibility.   The 
screening sheet is the first page of the data collection form.   
☐ 
N/A:  There is no screening as part of this protocol. 
9.0 Recruitment Methods 
☐ 
N/A:  This is a records review only, and subjects will not be recruited.  
NOTE:  If you select this option, please make sure that all records review 
procedures and inclusion/exclusion screening are adequately described in 
other sections. 
9.1 
Describe when, where, and how potential subjects will be recruited.  


NOTE:  Recruitment refers to how you are identifying potential participants and 
introducing them to the study.  Include specific methods you will use (e.g. searching charts 
for specific ICD code numbers, Research Participant Groups, posted advertisements, etc.). 
Response:  
Our study team will screen potential eligible patient by monitoring the patients’ Tracking 
Shell (OCH All Beds Only view) in the password protected Power chart system at the ED 
of John R. Oishei Children’s Hospital.  Patient needs blood work or IV fluid /medication 
treatment will be screened for eligibility.      
9.2 Describe how you will protect the privacy interests of prospective subjects during 
the recruitment process.   
NOTE:  Privacy refers to an individual’s right to control access to him or herself.   
Response:    
Our research team will approach the patient and the legal guardian in a patient’s private 
room at the ED.  The consent process will be done when no other staff is in the room.  
9.3 Identify any materials that will be used to recruit subjects.  
NOTE:  Examples include scripts for telephone calls, in person announcements / 
presentations, email invitations.  
For advertisements, include the final copy of printed advertisements with your 
submission. When advertisements are taped for broadcast, attach the final audio/video 
tape.  NOTE:  You may submit the wording of the advertisement prior to taping to ensure 
there will be no IRB-required revisions, provided the IRB also reviews and approves the 
final version. 
 Response:  
No materials will be used for recruitment for this study.  
10.0 
Procedures Involved 
10.1 Provide a description of all research procedures or activities being performed and 
when they are performed once a subject is screened and determined to be eligible. 
Provide as much detail as possible.   
NOTE:  This should serve as a blueprint for your study and include enough detail so that 
another investigator could pick up your protocol and replicate the research.  For studies 
that have multiple or complex visits or procedures, consider the addition of a schedule of 
events table in in your response. 
Response:  
Randomization of subject into one of the three  study arms 
There will be three arms of this study with each arm testing a different pain reducer: 
Buzzy Bee, Vapocoolant, and placebo. We will use a sham device e.g. a band around the 
arm for placebo control.     


After obtaining informed consent, the patients will be randomized into one of the three  
groups following a randomization table created by a statistician.   Whichever intervention 
is randomly selected will be performed on patient prior to the needle stick.  
These methods have been used in the ED as part of routine procedures to help patient for 
pain relief from a needle stick, the RNs are familiar with these methods.  However, for 
the purpose of this study, the training videos will be uploaded in the Kaleidascope Talent 
management for RNs to review the procedure and help them to refresh their memories.      
Videotaping of subject   
Using a camera, an ED research assistant will videotape subject’s whole body including 
the facial expression while phlebotomy and IV catheter placement is performed for 
scoring of the PBCL. We will tape the entire venipuncture procedure starting from 
sterilization and ending at the time when the venipuncture is completed.  If the first 
venipuncture procedure attempt is failed, we will not tape the second attempt.  This 
subject will be withdrawn from the study.  
Obtaining pain scores from subject and legal guardian using the Faces Pain Scale-
Revised instrument 
Before and after the venipuncture procedure, we will ask the legal guardian and subject to 
complete a Faces pain scale revised form. Since the revised form is validated to use for 
both adult and children, the same document will be used for the legal guardian and 
children for this study.  This document is attached with this submission.    
Reviewing of the videotape  
Two physicians will review the video tape independently, and give a score using the 
PBCL tool. These two physicians are blinded to the study aims.  They will be trained on 
how to use the PBCL by the PI.  
In the event when there is a discrepancy of the PBCL score between the two reviewers, 
the mean of the two scores will be used as the final score.  
10.2 Describe what data will be collected.   
NOTE:  For studies with multiple data collection points or long-term follow up, consider 
the addition of a schedule or table in your response. 
Response:  
We will collect demographic data, reason for venipuncture, PBCL score, facial pain score 
etc.  
10.3 List any instruments or measurement tools used to collect data (e.g. 
questionnaire, interview guide, validated instrument, data collection form).   
 
Include copies of these documents with your submission. 
Response:   
The following documents will be used for data collection: 
1. Data collection form 


2. Procedure behavior check list (PBCL) 
3. The Faces Pain scale-revised document.  
These documents will be submitted with this IRB application.  
10.4 Describe any source records that will be used to collect data about subjects (e.g. 
school records, electronic medical records). 
Response:  
Kaleida health Electronic power chart records will be used for data collection.  
10.5 Indicate whether or not individual subject results, such as results of investigational 
diagnostic tests, genetic tests, or incidental findings will be shared with subjects or 
others (e.g., the subject’s primary care physician) and if so, describe how these will 
be shared. 
Response:  
No individual subject results will be shared with the subject or others.  
10.6 Indicate whether or not study results will be shared with subjects or others, and if 
so, describe how these will be shared. 
Response:  
Study results will not be shared with subjects or others. The final results of this study 
may be presented at a conference or published in a peer reviewed journal; however, only 
group data will be publicized in these circumstances, no individual identifiable 
information will be released.  
11.0 
Study Timelines 
11.1 Describe the anticipated duration needed to enroll all study subjects. 
Response:  
We anticipate completing subject recruitment within 24 months of time.  
11.2 Describe the duration of an individual subject’s participation in the study. Include 
length of study visits, and overall study follow-up time. 
Response:  
The duration of the individual subject’s participation in this study will be 5-10 minutes. It 
will be ended when the patient completes the Facial pain scale sheet.  No study follow-up 
will be done for this project.  
11.3 Describe the estimated duration for the investigators to complete this study (i.e. all 
data is collected and all analyses have been completed). 
Response:  
The estimated duration for the investigators to complete the study will be 16 months. We 
will spend 24 months to recruit subject and another 3-4 months for data analysis.  
12.0 
Setting 


12.1 Describe all facilities/sites where you will be conducting research procedures.  
Include a description of the security and privacy of the facilities (e.g. locked 
facility, limited access, privacy barriers).  Facility, department, and type of room 
are relevant.  Do not abbreviate facility names.   
NOTE:  Examples of acceptable response may be:  “A classroom setting in the Department 
of Psychology equipped with a computer with relevant survey administration software,” 
“The angiogram suite at Buffalo General Medical Center, a fully accredited tertiary care 
institution within New York State with badge access,” or, “Community Center meeting 
hall.” 
Response:   
The consenting and videotaping process will be conducted in the private patient room in 
the ED at John R. Oishei Children’s Hospital.   Data collection will be completed by our 
research assistant at their desk in the ED, where the ED is bandage accessed.   The video 
tape will be reviewed at the UBMD Pediatric physician’s office located on the ID badge 
assessed 5th floor of the Conventus building (1001 Main St, Buffalo, NY 14203). 
12.2 For research conducted outside of UB and its affiliates, describe: 
 Site-specific regulations or customs affecting the research 
 Local scientific and ethical review structure 
NOTE:  This question is referring to UB affiliated research taking place outside UB, i.e. 
research conducted in the community, school-based research, international research, etc.  
It is not referring to multi-site research.  UB affiliated institutions include Kaleida Health, 
ECMC, and Roswell Park Cancer Institute.   
Response:   
☒ 
N/A:  This study is not conducted outside of UB or its affiliates. 
13.0 
Community-Based Participatory Research 
13.1 Describe involvement of the community in the design and conduct of the research.  
NOTE:  Community-Based Participatory Research (CBPR) is a collaborative approach to 
research that equitably involves all partners in the research process and recognizes the 
unique strengths that each brings.  CBPR begins with a research topic of importance to the 
community, has the aim of combining knowledge with action and achieving social change 
to improve health outcomes and eliminate health disparities. 
Response:  
☒ 
N/A:  This study does not utilize CBPR. 
13.2 
Describe the composition and involvement of a community advisory board. 
Response:  
☒ 
N/A:  This study does not have a community advisory board. 
14.0 
Resources and Qualifications 


14.1 Describe the qualifications (e.g., education, training, experience, expertise, or 
certifications) of the Principal Investigator and staff to perform the research.  When 
applicable describe their knowledge of the local study sites, culture, and society.  
Provide enough information to convince the IRB that you have qualified staff for the 
proposed research.  
NOTE:  If you specify a person by name, a change to that person will require prior 
approval by the IRB.  If you specify a person by role (e.g., coordinator, research assistant, 
co-investigator, or pharmacist), a change to that person will not usually require prior 
approval by the IRB, provided that the person meets the qualifications described to fulfill 
their roles. 
Response:  
The study PI Dr. Jill Fennell is a second year fellow physician in the Emergency 
Department of Oishei children’s Hospital, she is a certified pediatrician.  She has 
participated in clinical researches previously as Co-PI. 
Dr. Ted Andrew and Heather Territo will be the mentors for this project.  Dr. Andrew is 
an attending physician in general pediatrics department, and Dr. Territo is an attending in 
ED. Both of them have involved in numerous studies as PI and mentors in the past.    
The study coordinator has more than 14 years of experience in conducting clinical 
researches including drug trial, device trial, observational research, double blinded 
randomized drug trial, chart review study etc. She is familiar with good research practice 
regulations and rules.  She will be responsible for IRB submission and coordinating all 
study activities for this project.   
Dr. John Pastore, a pediatric hospitalist,   Dr. Kunal Chadha will be the double blinded 
observers.  They will review the tape and give a score based on the PBCL instrument.  
 The statistician, Dr. Brian Wrotniak, has extensive expertise in study design and 
data analysis.  He is responsible for study design and data analysis for this study.  
 
Describe other resources available to conduct the research.  
A group of research assistants in the ED will be involved in subject recruitment for this 
study under the supervision of the study coordinator.  
14.2 Describe the time and effort that the Principal Investigator and research staff will 
devote to conducting and completing the research. 
NOTE:  Examples include the percentage of Full Time Equivalents (FTE), hours per week.  
The question will elicit whether there are appropriate resources to conduct the research. 
Response:  
The research assistants work 7 days a week, 13 hours per day enrolling patients.  The PI 
will work 1-2 hours per week to address questions related with the study.  The two 
reviewers will work for about 2 hours per week to review the video tape.  
14.3 Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated consequences of the human research, if applicable. 


NOTE:  One example includes: on-call availability of a counselor or psychologist for a 
study that screens subjects for depression. 
Response:   
This study involves minimum risk to the participant. We will videotape participant’s 
whole body during the needle stick process. We do not anticipate any consequences 
related with the videotaping procedure.  
14.4 Describe your process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their duties 
and functions. 
Response:   
The PI, mentors and the study coordinator have involved in the development of the study 
protocol, they are very familiar with the study design and their duties and functions. 
The Research assistants will directly work under the supervision of the study 
coordinator. The RAs’ duties will include: screening potential eligible patient, 
obtaining consent/assent, videotaping patient and legal guardian as well as   
collecting data on data collection form.    
The study coordinator will provide training to all RAs before the RAs start 
patient’s recruitment. The training is focused on the following aspects: 
1. Review study protocol by presenting the materials to the RAs with a slide 
show. The RAs are required to understand the study aims/purpose and the detail 
of the study procedures.  
2. Review data collection forms. The RAs are required to know the inclusion and 
exclusion criteria for the study and know what kinds of patients are potentially 
eligible and need to be screened for the study. In addition, they will also be 
trained on how to collect data on the data collection form.  
3. Review the consent documents.  The RAs are required to know (a) the contents 
of the consent documents, (b) how to approach and introduce the study to the 
legal guardian and patient (c) how to address some of the common questions that 
the patient may have (d) immediately contact the study coordinator or PI for a 
question to which they do not know the answer.   
The coordinator will ask the RAs to practice the procedures of obtaining consent 
at the training meeting.      
4. The PI will train the study coordinator on how to use the camera to videotape 
patient.  Then the coordinator will train the RAs about this procedure.  Practice 
will be required as part of the training process.  
The training log will reflect areas of trainings and demonstrations of competence, 
including the method used, e.g. role play. The trainer and trainees names will be 
documented in the training log as one of the regulatory documents.  
All our RAs are CITI trained.  They have been helping on patient recruitments for 
a few other studies conducted in the ED and are very familiar with the patient 
recruitment and consenting procedures.  


  
15.0 
Other Approvals 
15.1 Describe any approvals that will be obtained prior to commencing the research 
(e.g., school, external site, funding agency, laboratory, radiation safety, or 
biosafety). 
Response:  
☒ 
N/A:  This study does not require any other approvals. 
16.0 
Provisions to Protect the Privacy Interests of Subjects 
 
16.1 Describe how you will protect subjects’ privacy interests during the course of this 
research. 
NOTE:  Privacy refers to an individual’s right to control access to him or herself.  Privacy 
applies to the person.  Confidentiality refers to how data collected about individuals for the 
research will be protected by the researcher from release.  Confidentiality applies to the 
data.   
Examples of appropriate responses include:  “participant only meets with a study 
coordinator in a classroom setting where no one can overhear”, or “the participant is 
reminded that they are free to refuse to answer any questions that they do not feel 
comfortable answering.”   
Response:  
Subject will be recruited at a private patient’s room in the ED where no other people are 
around beside the patient, their legal guardian, and the RN who performs the needle stick.   
16.2 Indicate how the research team is permitted to access any sources of information 
about the subjects.   
NOTE:  Examples of appropriate responses include:  school permission for review of 
records, consent of the subject, HIPAA waiver.  This question does apply to records 
reviews. 
Response:    
The PI and her mentors are physicians at the children’s hospital, they have been granted 
with the right to access the electronic power chart system by Kaleida Health IST to carry 
out their duties as physicians.  The research personnel also are granted with the right to 
access the power chart by Kaleida Health IST for carrying out their duties as researcher 
staff.   
In order to screen potential eligible patient for this study, we will also apply for a partial 
HIPAA waiver from our IRB.  
17.0 
Data Management and Analysis 
17.1 Describe the data analysis plan, including any statistical procedures.  This section 
applies to both quantitative and qualitative analysis.  


Response:  
All data analyses will be performed with SAS (version 9.2; SAS Institute, Inc., 
Cary, NC) and R (version 3.0.3) software.  Chi-square and Fisher’s exact test will 
be used to compare adverse events (e.g., systemic reaction, anaphylaxis, SOB, 
dyspnea, excess bleeding or hematoma formation), venipuncture and 
catheterization first attempt success, and number of patients with no to mild pain 
during needle insertion.   
The Kruskal-Wallis test will be used to compare each of the two observers’ assigned 
scores on the PBCL across three time periods: pre, procedure and post-procedure.  Pre-
procedure is defined as the time period prior to needle insertion including the placement 
of Vapocoolant, pain control or sham device up to needle insertion.  The procedure 
period is defined as needle insertion through withdrawal.  Post-procedure is defined as 
the 2 minute time period after needle withdrawal.  Only patient and observer pain scores 
will be used for first-time needle insertion. If first attempt is failed, subject will be 
withdrawn from the study. .  Comparisons of pain scores of the five intervention groups 
to placebo (sham device) will be analyzed via ANOVA.   
17.2 If applicable, provide a power analysis.   
NOTE:  This may not apply to certain types of studies, including chart/records reviews, 
survey studies, or observational studies.  This question is asked to elicit whether the 
investigator has an adequate sample size to achieve the study objectives and justify a 
conclusion.  
Response: 
For chi-square analysis, based on a medium effect size of 0.3, alpha of 0.05, degree of 
freedom of 8,  and 80% power it is estimated we will need a total of 168 subjects (56 per 
group). (QFAB Bioinformatics. 2015) 
17.3 Describe any procedures that will be used for quality control of collected data. 
Response:   
Our RA will double check the data form  to assure accuracy and completeness of data collection, 
if there is any missed data point,  the RA will fill in the missing information immediately.  
18.0 
Confidentiality 
 
A. Confidentiality of Study Data 
 
Describe the local procedures for maintenance of confidentiality of study data and any 
records that will be reviewed for data collection.   
 
18.1 
A.  Where and how will all data and records be stored?  Include information 
about:  password protection, encryption, physical controls, authorization of access, and 


separation of identifiers and data, as applicable.  Include physical (e.g. paper) and 
electronic files. 
Response:   
Completed paper data form with subject identifier and signed consent/assent 
documents will be placed in a locked study box in the ED.  The study coordinator 
will collect these documents on a daily basis.  The documents will be stored in a 
locked file cabinet in a research storage room (Conventus, Room 5201, 1001 
Main Street, Buffalo, NY 14203).  Each subject’s data form will be labeled with a 
unique study identify number (ID).  In addition, we will use a “subject 
enrollment log” to track subject’s enrollment and data entry status. This log is 
attached with this submission.  Subject’s ID, medical record number, enrollment 
date, and data entry date will be entered in this log.  This log will be stored in a 
locked file cabinet in the study coordinators’ office Room 5201 in the Conventus 
building.  
The data will be entered in a Microsoft excel spread sheet (Database) by a trained 
research assistant.  Database will be saved in a password protected UPA secure 
online drive.  No subject’s name, DOB, medical record number or Fin Number 
will be entered in the database.  The study ID number will be served as the code 
key to link the Database and the Subject enrollment log. We need to collect 
subject’s medical record number for the purpose of answering query.  
The study coordinator will transfer the subject’s video from the camera to a 
password protected secure UPA online folder, which will also be shared with the 
two physicians who will reviewed these videos. Then the coordinator will erase 
the video from the camera.          
The two trained physician observers will review the video saved on the password 
protected secure online folder at their Conventus offices and give a PSCL score 
for each subject.  Video will be  erased upon completing the study. 
18.2 
A.  How long will the data be stored? 
Response:  
Videotapes will be erased upon the end of the study.  Paper data form and subject 
enrollment log will be stored for three years after IRB closes this study.  Electronic data 
base will be stored indefinitely.  
18.3 
A.  Who will have access to the data? 
Response:  
The PI, study coordinator and research assistant that perform data entry will have access 
to the data. The two observers will access the video image data. 
18.4 
A.  Who is responsible for receipt or transmission of the data? 
Response:  
The study coordinator will be responsible for transmitting the data. 
18.5 
A.  How will the data be transported? 


Response: 
Everything will be transported manually.  
B. Confidentiality of Study Specimens 
 
Describe the local procedures for maintenance of confidentiality of study specimens.   
 
☒ 
N/A:  No specimens will be collected or analyzed in this research.   
(Skip to Section 19.0) 
 
18.6 
B.  Where and how will all specimens be stored?  Include information about:  
physical controls, authorization of access, and labeling of specimens, as applicable.   
Response:  
18.7 
B.  How long will the specimens be stored? 
Response:  
18.8 
B.  Who will have access to the specimens? 
Response:  
18.9 
B.  Who is responsible for receipt or transmission of the specimens? 
Response:  
18.10 B.  How will the specimens be transported? 
Response: 
 
19.0 
Provisions to Monitor the Data to Ensure the Safety of 
Subjects 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review procedures 
only.  This section does not apply. 
 
NOTE:  Minimal risk studies may be required to monitor subject safety if the research 
procedures include procedures that present unique risks to subjects that require monitoring.  
Some examples include:  exercising to exertion, or instruments that elicit suicidality or 
substance abuse behavior.  In such cases, N/A is not an acceptable response. 
 
19.1 Describe the plan to periodically evaluate the data collected regarding both harms 
and benefits to determine whether subjects remain safe. 
Response:   
This is an observational study, involves minimum risk to participant.  We do not 
anticipate any safety issue that may be related with the participation of this study. 


19.2 Describe what data are reviewed, including safety data, untoward events, and 
efficacy data. 
Response:  
Not applicable.  
19.3 Describe any safety endpoints. 
Response:   
Not applicable.  
19.4 Describe how the safety information will be collected (e.g., with case report forms, 
at study visits, by telephone calls with participants). 
Response:  
Not applicable. 
19.5 Describe the frequency of safety data collection. 
Response:   
Not applicable 
19.6 Describe who will review the safety data. 
Response:  
 Not applicable 
19.7 Describe the frequency or periodicity of review of cumulative safety data. 
Response:   
Not applicable 
19.8 Describe the statistical tests for analyzing the safety data to determine whether 
harm is occurring. 
Response:   
Not applicable 
19.9 Describe any conditions that trigger an immediate suspension of the research. 
Response:   
Not applicable 
20.0 
Withdrawal of Subjects 
☐ 
N/A:  This study is not enrolling subjects.  This section does not apply. 
 
20.1 Describe anticipated circumstances under which subjects may be withdrawn from 
the research without their consent. 
Response:   
If the first venipuncture procedure is failed, subject will be withdrawn from the study.  


20.2 Describe any procedures for orderly termination.   
NOTE:  Examples may include return of study drug, exit interview with clinician.  Include 
whether additional follow up is recommended for safety reasons for physical or emotional 
health. 
Response:  
If a subject is withdrawn from the study, we will not collect any data from the subject.    
20.3 Describe procedures that will be followed when subjects withdraw from the 
research, including retention of already collected data, and partial withdrawal 
from procedures with continued data collection, as applicable. 
Response:  
If a subject withdraws from the research in the ED, no study data will be collected for the 
study.  The signed consent/assent document will be kept in the file cabinet in the research 
office, Conventus building, Room 5201. 
21.0 
Risks to Subjects 
21.1 List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the 
subjects related to their participation in the research. Consider physical, 
psychological, social, legal, and economic risks.  Include a description of the 
probability, magnitude, duration, and reversibility of the risks.  
NOTE:  Breach of confidentiality is always a risk for identifiable subject data. 
Response:  
Some subjects may find the device a discomfort, however previous studies on devices 
show minimal risk for discomfort or hazards.  In addition, breach of confidentiality is the 
potential risk for this study. 
21.2 Describe procedures performed to lessen the probability or magnitude of risks, 
including procedures being performed to monitor subjects for safety. 
Response:  
Nurse will follow instruction when place the device on subject to avoid any unnecessary 
discomfort.  In addition, please refer to section 18 A for answers on protecting data 
confidentiality. 
21.3 If applicable, indicate which procedures may have risks to the subjects that are 
currently unforeseeable. 
Response:   
None 
21.4 If applicable, indicate which research procedures may have risks to an embryo or 
fetus should the subject be or become pregnant. 
Response:  
The devices have no known risk to embryo or fetus. 


21.5 If applicable, describe risks to others who are not subjects. 
Response:  
None 
22.0 
Potential Benefits to Subjects 
22.1 Describe the potential benefits that individual subjects may experience by taking 
part in the research.  Include the probability, magnitude, and duration of the 
potential benefits.  Indicate if there is no direct benefit.   
NOTE:  Compensation cannot be stated as a benefit. 
Response:  
A subject may experience less pain/ anxiety if he/she is provided with the device or the 
vapocoolant while the venipuncture procedure is performed.   
23.0 
Compensation for Research-Related Injury 
☒ 
N/A:  The research procedures for this study do not present risk of research 
related injury (e.g. survey studies, records review studies).  This section does not 
apply.   
23.1 
If the research procedures carry a risk of research related injury, describe the 
available compensation to subjects in the event that such injury should occur.   
Response: 
23.2 
Provide a copy of contract language, if any, relevant to compensation for 
research related injury. 
NOTE:  If the contract is not yet approved at the time of this submission, submit the current 
version here.  If the contract is later approved with different language regarding research 
related injury, you must modify your response here and submit an amendment to the IRB for 
review and approval. 
Response:  
24.0 
Economic Burden to Subjects 
24.1 Describe any costs that subjects may be responsible for because of participation in 
the research.   
NOTE:  Some examples include transportation or parking. 
Response:  
There is no cost for subjects to participate in this study. 
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
25.0 
Compensation for Participation 
25.1 
Describe the amount and timing of any compensation to subjects, including 
monetary, course credit, or gift card compensation. 


Response:  
☐ 
N/A:  This study is not enrolling subjects, or is limited to records review 
procedures only.  This section does not apply. 
☒ 
N/A:  There is no compensation for participation.  This section does not 
apply. 
26.0 
Consent Process 
26.1 Indicate whether you will be obtaining consent.   
NOTE:  This does not refer to consent documentation, but rather whether you will be 
obtaining permission from subjects to participate in a research study.   
Consent documentation is addressed in Section 27.0. 
☒ 
Yes 
(If yes, Provide responses to each question in this Section) 
☐ 
No 
(If no, Skip to Section 27.0) 
 
26.2 Describe where the consent process will take place.  Include steps to maximize 
subjects’ privacy. 
Response:   
The consent process will take place in the patient’s private room in the ED.  We will find 
the best time to approach the patients and their legal guardians for consenting purpose to 
avoid the interruption of patient’s care as well as to protect patient’s privacy.  No other 
people will be in the patient’s room beside the patient and the legal guardian when we 
obtain the consent.     
26.3 Describe how you will ensure that subjects are provided with a sufficient period of 
time to consider taking part in the research study.   
NOTE:  It is always a requirement that a prospective subject is given sufficient time to have 
their questions answered and consider their participation.  See “SOP: Informed Consent 
Process for Research (HRP-090)” Sections 5.5 and 5.6. 
Response:   
Enough time will be given to the legal guardian/participant to review the inform 
consent and to allow them understand the study completely, so they can make a 
clear informed decision.  All questions will be addressed before obtaining the 
signatures from the legal guardian/participant. 
26.4 Describe any process to ensure ongoing consent, defined as a subject’s willingness 
to continue participation for the duration of the research study.   
Response:   
This study does not involve follow-up procedure. The legal guardian and participant will 
be informed that they have right to withdraw from the study at any time before the 
consent is being signed. The PI’s contact information is listed in the informed consent. 


26.5 Indicate whether you will be following “SOP: Informed Consent Process for 
Research (HRP-090).” If not, or if there are any exceptions or additional details to 
what is covered in the SOP, describe: 
 
The role of the individuals listed in the application who are involved in the 
consent process 
 
The time that will be devoted to the consent discussion 
 
Steps that will be taken to minimize the possibility of coercion or undue 
influence 
 
Steps that will be taken to ensure the subjects’ understanding 
Response:  
☒ 
We have reviewed and will be following “SOP: Informed Consent Process for 
Research (HRP-090).” 
 
Non-English Speaking Subjects  
☒ 
N/A:  This study will not enroll Non-English speaking subjects.   
(Skip to Section 26.8) 
26.6 Indicate which language(s) other than English are likely to be spoken/understood 
by your prospective study population or their legally authorized representatives. 
 
NOTE: The response to this Section should correspond with your response to Section 6.4 of 
this protocol. 
Response:  
26.7 If subjects who do not speak English will be enrolled, describe the process to ensure 
that the oral and written information provided to those subjects will be in that 
language.  Indicate the language that will be used by those obtaining consent. 
NOTE:  Guidance is provided on “SOP:  Informed Consent Process for Research (HRP-
090).” 
Response:  
Cognitively Impaired Adults 
☒ 
N/A:  This study will not enroll cognitively impaired adults.   
(Skip to Section 26.9) 
26.8   Describe the process to determine whether an individual is capable of consent.  
Response:  
Adults Unable to Consent 
☒ 
N/A:  This study will not enroll adults unable to consent.  
(Skip to Section 26.13) 


When a person is not capable of consent due to cognitive impairment, a legally 
authorized representative should be used to provide consent (Sections 26.9 and 26.10) 
and, where possible, assent of the individual should also be solicited (Sections 26.11 
and 26.12). 
26.9  Describe how you will identify a Legally Authorized Representative (LAR).  
Indicate that you have reviewed the “SOP: Legally Authorized Representatives, 
Children, and Guardians (HRP-013)” for research in New York State.  
NOTE:  Examples of acceptable response includes: verifying the electronic medical record 
to determine if an LAR is recorded. 
Response:  
☐ 
We have reviewed and will be following “SOP: Legally Authorized 
Representatives, Children, and Guardians (HRP-013).”  
26.10 For research conducted outside of New York State, provide information that 
describes which individuals are authorized under applicable law to consent on 
behalf of a prospective subject to their participation in the research.  One method of 
obtaining this information is to have a legal counsel or authority review your 
protocol along with the definition of “legally authorized representative” in “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013).” 
Response:  
This study will not be performed outside of NYS.  
26.11 Describe the process for assent of the adults: 
 
Indicate whether assent will be obtained from all, some, or none of the 
subjects.  If some, indicate which adults will be required to assent and which 
will not. 
Response:  
 
If assent will not be obtained from some or all subjects, provide an 
explanation of why not. 
Response:  
26.12 Describe whether assent of the adult subjects will be documented and the process 
to document assent.   
NOTE:  The IRB allows the person obtaining assent to document assent on the consent 
document using the “Template Consent Document (HRP-502)” Signature Block for Assent 
of Adults who are Legally Unable to Consent. 
Response:  
Subjects who are not yet Adults (Infants, Children, and Teenagers) 
☐ 
N/A:  This study will not enroll subjects who are not yet adults.   
(Skip to Section 27.0) 
26.13 Describe the criteria that will be used to determine whether a prospective subject 
has not attained the legal age for consent to treatments or procedures involved in 


the research under the applicable law of the jurisdiction in which the research will 
be conducted (e.g., individuals under the age of 18 years).  For research conducted 
in NYS, review “SOP: Legally Authorized Representatives, Children, and 
Guardians (HRP-013)” to be aware of which individuals in the state meet the 
definition of “children.”  
NOTE:  Examples of acceptable responses include: verification via electronic medical 
record, driver’s license or state-issued ID, screening questionnaire. 
Response:  
This study is conducted in NYS; we will use the SOP HRP-013 as the criteria to 
determine if a subject is not yet an adult. We will check patient’s birthdays in the 
electronic medical chart.  
26.14For research conducted outside of New York State, provide information that 
describes which persons have not attained the legal age for consent to treatments or 
procedures involved the research, under the applicable law of the jurisdiction in 
which research will be conducted.  One method of obtaining this information is to 
have a legal counsel or authority review your protocol along the definition of 
“children” in “SOP: Legally Authorized Representatives, Children, and Guardians 
(HRP-013).” 
Response:  
This study will be conducted only in NYS. 
26.15 Describe whether parental permission will be obtained from: 
Response:  
☒  One parent even if the other parent is alive, known, competent, reasonably 
available, and shares legal responsibility for the care and custody of the child. 
☐ 
Both parents unless one parent is deceased, unknown, incompetent, or not 
reasonably available, or when only one parent has legal responsibility for the care 
and custody of the child. 
☐ 
Parent permission will not be obtained.  A waiver of parent permission is being 
requested. 
NOTE:  The requirement for parent permission is a protocol-specific determination made 
by the IRB based on the risk level of the research.  For guidance, review the 
“CHECKLIST: Children (HRP-416).”  
26.16Describe whether permission will be obtained from individuals other than parents, 
and if so, who will be allowed to provide permission.  Describe your procedure for 
determining an individual’s authority to consent to the child’s general medical 
care. 
Response:  
Parental permission will be obtained from the subject’s legal guardian who could be an 
individual other than the parents. These individuals need to show the legal document to 


our ED registration staff for their authorities to consent the children for medical care. We 
will approach the patient and his/her legal guardian for study consenting purpose after the 
patient is being registered.  
26.17 Indicate whether assent will be obtained from all, some, or none of the children.  If 
assent will be obtained from some children, indicate which children will be 
required to assent. 
Response:  
Assent will be obtained from all children who are between 7-17 years of age.  
26.18 When assent of children is obtained, describe how it will be documented. 
Response:   
Children will sign their names on the assent document. 
27.0 
Waiver or Alteration of Consent Process 
Consent will not be obtained, required information will not be disclosed, or the 
research involves deception. 
☒ 
N/A:  A waiver or alteration of consent is not being requested. 
27.1 If the research involves a waiver or alteration of the consent process, please review 
the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-410)” to ensure 
that you have provided sufficient information for the IRB to make the determination 
that a waiver or alteration can be granted.   
NOTE:  For records review studies, the first set of criteria on the “CHECKLIST: Waiver or 
Alteration of Consent Process (HRP-410)” applies.  
Response:  
27.2 If the research involves a waiver of the consent process for planned emergency 
research, please review the “CHECKLIST: Waiver of Consent for Emergency 
Research (HRP-419)” to ensure you have provided sufficient information for the 
IRB to make these determinations.  Provide any additional information necessary 
here: 
Response:  
28.0 
Process to Document Consent 
☐ 
N/A:  A Waiver of Consent is being requested.   
(Skip to Section 29.0) 
28.1 Indicate whether you will be following “SOP: Written Documentation of Consent 
(HRP-091).” If not or if there are any exceptions, describe whether and how 
consent of the subject will be obtained including whether or not it will be 
documented in writing.   
NOTE:  If your research presents no more than minimal risk of harm to subjects and 
involves no procedures for which written documentation of consent is normally required 
outside of the research context, the IRB will generally waive the requirement to obtain 


written documentation of consent.  This is sometimes referred to as ‘verbal consent.’  
Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-411)” to 
ensure that you have provided sufficient information.  
If you will document consent in writing, attach a consent document with your 
submission.  You may use “TEMPLATE CONSENT DOCUMENT (HRP-502)”.  If you 
will obtain consent, but not document consent in writing, attach the script of the 
information to be provided orally or in writing (i.e. consent script or Information Sheet).   
Response:  
☒ 
We will be following “SOP:  Written Documentation of Consent” 
(HRP-091). 
29.0 
Multi-Site Research (Multisite/Multicenter Only) 
☒ 
N/A:  This study is not an investigator-initiated multi-site study.  This section 
does not apply. 
 
29.1 If this is a multi-site study where you are the lead investigator, describe the 
processes to ensure communication among sites, such as: 
 
All sites have the most current version of the IRB documents, including the 
protocol, consent document, and HIPAA authorization. 
 
All required approvals have been obtained at each site (including approval by 
the site’s IRB of record). 
 
All modifications have been communicated to sites, and approved (including 
approval by the site’s IRB of record) before the modification is implemented. 
 
All engaged participating sites will safeguard data as required by local 
information security policies. 
 
All local site investigators conduct the study appropriately. 
 
All non-compliance with the study protocol or applicable requirements will be 
reported in accordance with local policy. 
Response:  
29.2 Describe the method for communicating to engaged participating sites: 
 
Problems 
 
Interim results 
 
Study closure 
Response:  
29.3 
Indicate the total number of subjects that will be enrolled or records that will be 
reviewed across all sites. 
Response:  
29.4 
If this is a multicenter study for which UB will serve as the IRB of record, and 
subjects will be recruited by methods not under the control of the local site (e.g., call 
centers, national advertisements) describe those methods.  


Response:  
30.0 
Banking Data or Specimens for Future Use 
☒ 
N/A:  This study is not banking data or specimens for future use or research 
outside the scope of the present protocol.  This section does not apply. 
30.1 If data or specimens will be banked (stored) for future use, that is, use or research 
outside of the scope of the present protocol, describe where the data/specimens 
will be stored, how long they will be stored, how the data/specimens will be 
accessed, and who will have access to the data/specimens.  
NOTE:  Your response here must be consistent with your response at the “What happens if 
I say yes, I want to be in this research?” Section of the Template Consent Document (HRP-
502). 
Response:    
30.2 List the data to be stored or associated with each specimen. 
Response:  
30.3 Describe the procedures to release banked data or specimens for future uses, 
including: the process to request a release, approvals required for release, who can 
obtain data or specimens, and the data to be provided with specimens. 
Response:   
31.0 
Drugs or Devices 
☐ 
N/A:  This study does not involve drugs or devices.  This section does not apply. 
31.1 If the research involves drugs or devices, list and describe all drugs and devices 
used in the research, the purpose of their use, and their regulatory approval status.  
Response:  
Device:  
The devices that will be used for this study are: Buzzy Bee (MMJ Labs LLC).    It is a 
FDA approved device for decreasing pain and anxiety for vaccination shots and other 
venipuncture procedure in pediatric patients.   
The FDA approval for the Buzzy Bee is attached with this submission.  
In addition, a Fujifilm XP camera will be used for videotaping purpose.   
Vapocoolant  
Vapocoolant (Gebauer’s ethyl chloride, Gebauer company) will be used in this study. It 
has also been approved by FDA to use on pediatric patient for providing local anesthesia 
for venipuncture procedures. A FDA approval is attached with this submission.  
31.2 Describe your plans to store, handle, and administer those drugs or devices so that 
they will be used only on subjects and be used only by authorized investigators. 
Response:   


The Buzzy Bee   and   vapocoolant are stored in the medication room in the Pixis which 
is secured and locked; it can only be opened to those who have badge access. The 
Camera will be held in the same place. The Buzzy ice wing will be stored in a freezer 
inside of the ED.   
If the drug is investigational (has an IND) or the device has an IDE or a claim of 
abbreviated IDE (non-significant risk device), include the following information: 
31.3 Identify the holder of the IND/IDE/Abbreviated IDE. 
Response:  
 Not applicable.  
31.4 Explain procedures followed to comply with FDA sponsor requirements for the 
following:   
 
Applicable to:
FDA Regulation 
IND Studies 
IDE studies 
Abbreviated IDE 
studies 
21 CFR 11
X
X
21 CFR 54
X
X
21 CFR 210
X
21 CFR 211
X
21 CFR 312
X
21 CFR 812
X
X
21 CFR 820
X
Response:    
32.0 
Humanitarian Use Devices 
☒ 
N/A:  This study does not involve humanitarian use devices.  This does not apply. 
32.1 
For Humanitarian Use Device (HUD) uses provide a description of the device, a 
summary of how you propose to use the device, including a description of any screening 
procedures, the HUD procedure, and any patient follow-up visits, tests or procedures. 
Response:  
32.2 
 For HUD uses provide a description of how the patient will be informed of the 
potential risks and benefits of the HUD and any procedures associated with its use. 
Response:  


Data Management and Analysis 
 
All data analyses will be performed with SAS (version 9.2; SAS Institute, Inc., Cary, NC) and R (version 
3.0.3) software.  Chi-square and Fisher’s exact test will be used to compare adverse events (e.g., 
systemic reaction, anaphylaxis, SOB, dyspnea, excess bleeding or hematoma formation), venipuncture 
and catheterization first attempt success, and number of patients with no to mild pain during needle 
insertion.   
The Kruskal-Wallis test will be used to compare each of the two observers’ assigned scores on the PBCL 
across three time periods: pre, procedure and post-procedure.  Pre-procedure is defined as the time 
period prior to needle insertion including the placement of Vapocoolant, pain control or sham device up 
to needle insertion.  The procedure period is defined as needle insertion through withdrawal.  Post-
procedure is defined as the 2 minute time period after needle withdrawal.  Only patient and observer 
pain scores will be used for first-time needle insertion. If first attempt is failed, subject will be withdrawn 
from the study. .  Comparisons of pain scores of the five intervention groups to placebo (sham device) 
will be analyzed via ANOVA.   
For chi-square analysis, based on a medium effect size of 0.3, alpha of 0.05, degree of freedom of 8,  and 
80% power it is estimated we will need a total of 168 subjects (56 per group). (QFAB Bioinformatics. 
2015) 
 
 
 
 
 
 

ICF_001.pdf: 
 
Official Title: 
A Randomized Clinical Trial of Buzzy versus Vapocoolant 
in Pain Relief during a venipuncture procedure in a 
pediatric Emergency Room  
NCT number: 
unavailable 
Document Type: 
Legal guardian consent  
Date of the 
Document: 
December 17, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Parental Permission form  
Title of research study:  A randomized clinical trial of buzzy versus 
vapocoolant in pain relief during a venipuncture procedure in a pediatric 
Emergency Room 
Version Date:  December 17, 2019 
Investigator: Dr. Jill C Fennell  
Key Information: The following is a short summary of this study to help you decide 
whether or not to let your child to be a part of this study. More detailed information is listed later 
on in this form. 
Why is my child being invited to take part in a research study? 
Your child is being invited to take part in a research study because he/she is in need of blood 
work, and/or an intravenous (IV) line placement for medications.   
What should I know about a research study? 
Someone will explain this research study to you. 
Whether or not you let your child take part is up to you. 
You can choose not to let your child take part. 
You can agree to let your child take part and later change your mind. 
Your decision will not be held against you or your child. 
You can ask all the questions you want before you decide. 
Why is this research being done? 
Placement of intravenous (IV) line and taking blood sample are common practices in the 
pediatric Emergency department for work up and treatment. Unmanaged needle stick pain in 
pediatric patients have been associated with needle phobia, greater pain with future sticks, 
anxiety associated with other medical procedures, healthcare avoidance and increased adult pain 
sensitivity. 
Different methods have been used for management of acute pain associated with needle sticks. 
Among them, vapocoolants, and buzzy are frequently used methods to help pediatric patients for 
pain relief related with the needle sticks. Vapocoolants are volatile refrigerated liquids used prior 
to the needle sticks.  The buzzy is a vibrating palm-sized device with removable ice wings used 
during the needle sticks.    
Some research results show that vapocoolants are ineffective in children when compared to 
placebo or no treatment. The investigators believe that the sensation of cold on a child’s skin 
may be perceived as painful by the child.  
The main purpose of this study is to compare the effectiveness of pain relief using different 
methods, the buzzy, vapocoolant and placebo while the patient is having an IV line placement or 
a blood draw.  
 


 How long will the research last and what will my child need to do? 
We expect that your child will be in this research study for about 10 minutes.   
Your child will be randomly assigned into one of the three study groups, i.e. the buzzy bee 
vapocoolant or placebo, and receive the assigned intervention before or during the needle 
insertion procedure. Meanwhile, our research team will take a videotape of your child while the 
nurse is doing the needle insertion. .     
More detailed information about the study procedures can be found under “What happens if I 
say yes, I want my child to be in this research?” 
Is there any way being in this study could be bad for my child? 
This study involves no more than minimum risk to the participants.  Participant may have a local 
reaction to the device used.  If that happens to your child, your child may not be included in the 
research study.  
More detailed information about the risks of this study can be found under “Is there any way 
being in this study could be bad for my child? (Detailed Risks)” 
Will being in this study help my child in any way? 
 There are no benefits to your child from his/her taking part in this research. We also cannot 
promise any benefits to others from your child’s taking part in this research.   
What happens if I do not want my child to be in this research? 
Participation in research is completely voluntary. You may choose not to let your child enroll in 
this study.  
Your child’s alternative to participating in this research study is to not participate. 
Detailed Information: The following is more detailed information about this study in 
addition to the information listed above. 
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has hurt your child, 
talk to the research team at 716-323-0055.  You may also contact the research participant 
advocate at 716-888-4845 or researchadvocate@buffalo.edu.  
This research has been reviewed and approved by an Institutional Review Board (“IRB”). An 
IRB is a committee that provides ethical and regulatory oversight of research that involves 
human subjects. You may talk to them at (716) 888-4888 or email ub-irb@buffalo.edu if:  
 You have questions about your child’s rights as a participant in this research 
Your questions, concerns, or complaints are not being answered by the research team. 
You cannot reach the research team. 
You want to talk to someone besides the research team. 
You want to get information or provide input about this research. 


How many people will be studied? 
We expect about 168 people here will be in this research study.   
What happens if I say yes, I want my child to be in this research? 
If you decide to let your child take part in this study, your child will receive one of the three pain 
relief methods for the placement of IV line or blood draw.  Your child will be randomly assigned 
into one of the three groups:  buzzy bee, vapocoolant, or placebo.  
The method your child gets will be chosen by chance, like flipping a coin. Neither you nor we 
will choose what method your child gets. Your child will have an equal chance of receiving each 
of the three methods. 
While the nurse is taking blood or placing IV line, we will videotape your child. The 
investigators will review the tape later on and give pain scores related with the procedure.   
We will also ask you and your child to complete a pain evaluation form before and after the 
needle sticks procedure.   
Other than these study procedures, your child will receive routine medical care. Your child 
participation in this study will end once you and your child complete the post needle stick pain 
evaluation form.  
What are my responsibilities if my child take part in this research? 
If your child takes part in this research, you and your child will be responsible for filling out two 
forms for assessing your child’s pain related with the needle stick.  
What happens if I say yes, but I change my mind later? 
Your child can leave the research at any time and it will not be held against you or your child.  
If you decide to let your child leave the study, let the research team know, so we will stop the 
study procedure immediately.  
If your child stops being in the research, already collected data may not be removed from the 
study database. You will be asked whether the investigator can continue collecting data from 
your child’s routine medical care.  If you agree, this data will be handled the same as other 
research data.   
Is there any way being in this study could be bad for my child? 
(Detailed Risks) 
This study involves no more than minimum risk to the participants.  Participant may have a local 
reaction to the device used.  If that happens to your child, your child may not be included in the 
research study.  
In addition, breaching confidentially is a potential risk for this study. We will take all precautions 
to prevent this from happening. 
We will videotape your child for this study, which is also a confidentiality risk. The study 
coordinator will transfer the video from the camera to a password protected secure online drive. 
Then she will erase the video from the camera.  The video images saved on the secure online 
drive will be erased at the end of the study.  


The device and the vapocoolant used in this study have been approved by Food and Drug 
Administration (FDA) for releasing pain associated with needle sticks.   
What happens to the information collected for the research? 
All research data collected for this study will be locked up in secure file cabinet in the research 
office.  The video will be erased from the camera after being saved in a password protected 
online secure drive.   Only the study coordinator and the investigators can gain access to the data 
and video. Video will be erased from the online secure drive at the end of the study. 
Your child’s information that are collected as part of this research will not be used or distributed 
for future research studies, even if all of your child’s identifiers are removed. 
Efforts will be made to limit the use and disclosure of your child’s personal information, 
including research study and medical or education records, to people who have a need to review 
this information. We cannot promise complete secrecy. Organizations that may inspect and copy 
your child’s information include the IRB and other representatives of this organization.  
If the research team uncovers possible concerns for abuse, neglect or reportable diseases this 
information may be disclosed to the appropriate authorities. 
The IRB and the FDA will be granted direct access to your child’s medical records to conduct 
and oversee the research. By signing this document you are authorizing this access. We may 
publish the results of this research. However, we will keep your child’s name and other 
identifying information confidential. 
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 your child. At most, 
the Web site will include a summary of the results. You can search this Web site at any time. 
Federal law provides additional protections of your child’s medical records and related health 
information. These are described in the HIPAA section of this document. 
Can my child be removed from the research without my OK? 
 The person in charge of the research study or the sponsor can remove you from the research 
study without your approval. Possible reasons for removal include needing more than one try for 
inserting the IV line or taking blood draw. Your child may also be removed if there is a problem 
with the video tape or the FACES scale.  
What else do I need to know? 
 The results of this research may be presented at conference and published in a scientific journal, 
but the results will be presented as group data, and no participant’s identity will be published.  
You or your child will not be paid for participating in this study. 
 
 
 
 


 
 
 
 
 
 
 
  
 
HIPAA:  Authorization for the Use and Disclosure of Identifiable 
Health Information for Research Purposes   
This section describes information about your child and about your child’s health 
information that will be obtained by the researchers when your child participates in the 
research study. By signing this form you are agreeing to permit the researchers and/or other 
parties (described in detail below) to have access to this information and to use or disclose it 
for the purposes of the research described in this document.  If there are any parts of this 
form that you do not understand, please be sure to ask us for further clarification. 
 
A. What individually identifiable health information will be collected about your 
child as part of this research study? 
  
__X___  Information from your child’s full medical records: Demographic data, ED visit 
date and time.  
___x__    New Health Information created from study related tests, procedures, visits, 
and/or   questionnaires as described in this consent form. 
 
B.    Who is authorized to create or provide this information for research use?   
 
___x__      KALEIDA Health, Buffalo NY 
 
C.    Who is authorized to receive the information from the information providers 
identified in (B)? 
 
__x_       Principal Investigator or designee 
 
D.   With whom may your child’s protected health information be shared?  
 
Your child’s health information may be shared with others outside of the research group 
for purposes directly related to the conduct of this research study or as required by law, 
including but not limited to: 
  


 __x___  Other medical investigators participating in this research study including the 
doctors who will be watching the videos 
 
Your child’s information may also be shared with individuals or entities responsible for 
general administration, oversight and compliance of research activities. Examples of this 
include the institution's Privacy and Security Officers or other internal oversight staff, 
Safety Monitoring Boards, an Institutional Review Board, The Research Foundation of 
the State University of New York, University at Buffalo Foundation Services, and 
accrediting bodies, or with certain government oversight agencies that have authority 
over the research including the Department of Health and Human Services (HHS), the 
Food and Drug Administration (FDA), the National Institutes of Health (NIH), and the 
Office of Human Research Protections (OHRP). Your child’s information may also be 
shared with other entities as permitted or required by law. All reasonable efforts will be 
used to protect the confidentiality of your individually identifiable health information that 
may be shared with others as described above.   
 
Although safeguards are in place to prevent accidental disclosure of your information 
beyond the purposes described above, the information disclosed through this 
authorization is no longer protected by HIPAA.   There is the potential for this 
information to be re-disclosed by the recipient(s). After such a disclosure, the information 
may no longer be protected by the terms of this authorization against further re-
disclosure. 
 
E.  How long are the information providers listed in (B) authorized to provide your 
child’s information for this research project? 
   
__ x ___  b.  This authorization will expire at the end of the research study. After that 
time, this authorization may not be used to acquire additional information about 
your child. 
  
___ x __  d.  Your child’s protected health information will go into a database that will be 
maintained indefinitely. Any future study using this information that falls 
outside the scope of this current study will be required to follow guidelines 
designed to govern access to that information and to protect the privacy of that 
information.  The researchers may continue to rely on this authorization to 
acquire protected health information about your child unless you revoke this 
authorization in writing. 
 
F.  What are your rights after signing this authorization? 
 
You have the right to revoke this authorization at any time. If you withdraw your 
authorization, no additional efforts to collect individually identifiable health information 
about your child will be made. You should know, however, that protected health 
information acquired using this authorization prior to its withdrawal may continue to be 
used to the extent that the investigator(s) have already relied on your permission to 
conduct the research. If you chose to withdraw this authorization, you must do so in 
writing to the following individual(s):  


 
Dr. Jill C Fennell 
Division of Emergency Medicine 
UMMD Pediatrics 
5th Floor, Conventus Building 
1001 Main Street,   
Buffalo NY 14203 
 
If you send us a request to withdraw your authorization, we will forward that request to 
the institutions we have shared it with in order to collect your child’s individually 
identifiable health information. 
 
G.  What will happen if you decide not to sign this authorization? 
 
Refusing to sign this authorization will not affect the present or future care your child 
receives at this institution and will not cause any penalty or loss of benefits to which your 
child is   otherwise entitled. If you decide not to sign this authorization, your child will 
not be able to participate in the research study.   
 
Should you agree to participate in this research, this consent document will be placed in   
your child’s medical record.     
 
 


 Signature Block for Parental Permission 
Your signature documents your permission for the named child to take part in 
this research. By signing this form you are not waiving any of your legal rights, 
including the right to seek compensation for injury related to negligence or 
misconduct of those involved in the research. 
 
 
 
Printed name of child 
 
 
 
Signature of parent or individual legally authorized to 
consent to the child’s general medical care 
 
Date 
 
 Parent 
 Individual legally 
authorized to consent to 
the child’s general 
medical care (See note 
below)
Printed name of parent or individual legally authorized 
to consent to the child’s general medical care 
Note: Investigators are to ensure that individuals who are not parents can demonstrate their 
legal authority to consent to the child’s general medical care. Contact legal counsel if any 
questions arise. 
  
  
Assent 
 Obtained 
 Not obtained because the capability of the child is so limited that the child cannot reasonably be 
consulted. 
 
 
 
 
Signature of person obtaining consent  
 
Date 
 
 
Printed name of person obtaining consent