Clinical trial NCT01516684
Conditions: Malignant Neoplasm
Sponsor: Wake Forest University Health Sciences
Start date: 2012-05-14; Completion date: 2018-06-26
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site will decrease the total dose of propofol administered to pediatric oncology patients who are being sedated for LPs compared to application of a topical placebo cream.

SECONDARY OBJECTIVES:

I. To determine whether the use of EMLA cream decreases complication rates from sedation.

II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures.

III. To determine whether the use of EMLA cream shortens recovery time. IV. To determine practitioner and parent satisfaction with the use of EMLA cream.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

ARM II: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.

After completion of study treatment, patients are followed up within 1 week.

Arms: arm 1: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol. arm 2: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
Interventions: intervention 1: placebo administration intervention 2: EMLA intervention 3: propofol intervention 4: fentanyl citrate
Intervention descriptions: intervention 1: Given topically intervention 2: Given topically intervention 3: Given IV intervention 4: Given IV

Protocol documents:
Prot_SAP_001.pdf: 
1 
 
Version 1   7/19/2012 
Study Title: A Randomized, Double Blind Trial of Pediatric Lumbar Puncture under 
Sedation/Total Intravenous Anesthesia (TIVA) with and without EMLA cream 
 
 
Principal Investigator: Principal Investigator: Thomas McLean, MD  
Co- Principal Investigator: Melanie Rodgers 
Co-investigator(s) Allison McBride MD  
 
 
 
Background, Rationale and Context 
Pediatric Sedation/Total Intravenous Anesthesia (TIVA) outside the operating room is a 
growing field, especially in children’s hospitals. One particular area of demand for 
pediatric sedation/TIVA is procedures for patients with hematologic malignancies. These 
children often require multiple lumbar punctures (LPs) and bone marrow aspirates. For 
example, an individual patient diagnosed with acute lymphocytic leukemia (ALL) 
typically undergoes approximately 20 TIVAs for lumbar punctures with intrathecal 
chemotherapy over a two to three year period. Pediatric intensivists at Brenner Children’s 
Hospital administer approximately 1200 cases of TIVA per year, and recently have 
trained pediatric hospitalists to do the same. Pediatric TIVA has inherent risks. Many 
different medications can be used to achieve an appropriate level of anesthesia, all with 
different side effect profiles that could be potentially harmful to the patient.1  
  
Propofol is a widely used anesthetic for TIVA in such patients. Propofol is a general 
anesthetic administered intravenously. Propofol acts rapidly and is metabolized quickly, 
providing TIVA for short duration procedures.2 While generally safe and effective, 
propofol must be delivered by physicians explicitly trained in its use and able to deal with 
common side effects like bradycardia, hypotension, and apnea.3 Coadministration of 
narcotics such as fentanyl provides analgesia, which propofol does not provide, but also 
can exacerbate side effects. Decreasing the total dose of propofol shortens recovery time 
and may be associated with less undesirable side effects.  
 
EMLA cream (lidocaine 2.5% and prilocaine 2.5%) is an FDA-approved local anesthetic 
indicated for numbing skin prior to injections and other medical procedures. It is 
commonly used in pediatric patients prior to painful injections. It is sometimes used prior 
to LPs, but there is no consistent practice among practitioners or institutions. In children 
undergoing an LP, the level of anesthesia is balanced with the ability of the practitioner to 
perform the procedure safely with little to no patient movement. We frequently observe 
patient movement upon needle insertion despite a “standard” loading dose of propofol (2 
mg/kg). Such movement appears reflexive, and to eliminate it requires further propofol 
boluses, leading to longer recovery times and exposing the patient to higher total propofol 
doses. We have also observed that patients who have EMLA cream applied to the LP site 
prior to sedation tend to have less movement than those not treated with EMLA. There 
have been no randomized trials to date, however, assessing EMLA’s efficacy for LP. 
 
 


2 
 
Version 1   7/19/2012 
Hypothesis: The application of a eutectic mixture of local anesthetic (EMLA) cream at 
least 60 minutes before an LP will lead to less total dose of propofol and shorter, safer 
TIVA experience, compared to application of a placebo cream. We also hypothesize that 
parents and practitioners will be more satisfied with the TIVA experience with EMLA 
cream compared to placebo cream. 
 
Objectives 
1. Primary objective: To determine whether the application of a topical 
anesthetic (EMLA cream) to the LP site will decrease the total dose of 
propofol administered to pediatric oncology patients who are being sedated 
for LPs compared to application of a topical placebo cream. 
2. Secondary objectives: 
a. To determine whether the use of EMLA cream decreases complication 
rates from sedation  
b. To determine whether the use of EMLA cream decreases traumatic 
lumbar punctures. 
c. To determine whether the use of EMLA cream shortens recovery time. 
d. To determine practitioner and parent satisfaction with the use of 
EMLA cream. 
 
Methods and Measures 
 
Design 
 This will be a prospective, randomized, double blind, placebo-
controlled trial. 
 Arm 1 = Arm A = Real EMLA cream 
 Arm 2 = Arm B = Placebo cream 
 
Setting 
Single site study in the Pediatric Sedation Suite, 8th floor of Brenner Children’s 
Hospital (Ardmore West) at Wake Forest University Medical Center, Winston-
Salem, NC. 
 
Subjects selection criteria 
 Inclusion Criteria 
Pediatric oncology patients (age 0 – 22 years) undergoing a lumbar puncture 
in the Pediatric Sedation Suite. Patients may or may not be receiving 
intrathecal chemotherapy.  
o Exclusion Criteria-Patients undergoing additional procedures during 
the same anesthetic such as bone marrow aspirate or biopsy will be 
excluded because they will likely require higher doses of propofol than 
those undergoing LP alone.  
o Patients who are allergic to or not tolerant of EMLA cream, propofol, 
or fentanyl will be excluded. 
o Patients having their LPs done by students will be excluded. 
 Sample Size 


3 
 
Version 1   7/19/2012 
Our target accrual is a total of 200 events (sedation with lumbar puncture). 
Patients may be enrolled multiple times (one time for each sedation). Each 
patient may undergo randomization as many times as they are willing to stay 
on study and they are having sedation for a lumbar puncture. We anticipate 
enrolling approximately 20 subjects per year, with a mean of 5 events per 
patient per year. Thus, we hope to have 100 events per year for 2 years, for a 
total of 200 events. If we enroll 20 subjects per year for 2 years, the total 
number of subjects for this protocol will equal 40.   
 
We present power calculations for the dichotomous outcome of whether 
additional propofol was administered (yes/no). With 100 sedations with 
lumbar puncture in each sedation group (EMLA cream and no EMLA cream), 
using a two-sided 0.05 level chi-square test of equal proportions the following 
table presents effect sizes we have 80% and 90% power to detect. 
 
Proportion of additional doses 
in EMLA cream group 
Alternative proportion of additional doses 
80% power 
90% power 
5% 
17.4% 
20.0% 
10% 
25.0% 
27.8% 
20% 
37.9% 
40.9% 
40% 
59.7% 
62.7% 
60% 
78.2% 
80.7% 
  
We present power calculations for the continuous outcome of total dose of 
propofol administered. Using a two-sided 0.05 level two sample t-test of equal 
means, with 100 sedations with lumbar puncture in each sedation group we 
have 80% and 90% power to detect effect sizes of 0.398 and 0.461 
respectively. 
 
Interventions and Interactions 
 Eligible patients will be approached in the Pediatric Oncology Clinic and 
offered participation in the trial. 
 If they agree, signed consent and assent (for patients age 7-17 years) will be 
obtained. 
 Enrollment and randomization will be done through the Comprehensive 
Cancer Center  
o Call Lisa Dixon and let her know a patient has signed 
consent/assent  
 Phone (336) 713-6767 
 Back up phone (336) 713-6929 
o The enrollment form will be emailed or faxed to Lisa Dixon 
 Fax (336) 713-6772 
 Email can be done online at: 
http://ccc.wfubmc.edu/Reduced-Review-Registration-
Form.pdf 


4 
 
Version 1   7/19/2012 
o Ms. Dixon will enroll and randomize the patient, and call the clinic 
back (713-5940) to tell Nancy Smith, RN or her designee the 
randomization result  
 Arm 1 = Arm A = Real EMLA cream 
 Arm 2 = Arm B = Placebo cream 
o Nurse Smith or her designee will apply the appropriate cream 
without telling the patient or practitioner in clinic (who will be 
performing the LP) which cream is being applied. Both creams 
should be present in the room before application, so that the patient 
and the patient’s family will not know which one will be used. 
(They will be instructed not to look while the cream is being 
applied.) The sedation team will also not be told which cream is 
being applied. 
 Without the patient or patient’s family watching, EMLA cream or placebo 
EMLA cream will be applied to the patients’ lumbar spine area at the site of 
the LP, at least 60 minutes prior to the LP (maximum 4 hours). Patients and 
their parents will not be told whether real or placebo cream is being used. 
 Placebo cream will be a generic moisturizing skin cream which has the same 
color (white) and consistency as EMLA cream. It will not be labeled, but will 
be dispensed from a multi-use jar.  The placebo cream is a generic Walgreen’s 
Moisture Recovery Lotion. It is hypoallergenic and fragrance free.  The 
ingredients include: Water, Glycerin, Petroleum, Stearic Acid, Glycol 
Stearate, Isopropyl Isostearate, Dimethicone, Tapioca Starch, Cetyl Alcohol, 
Glyceryl Stearate, Magnesium Aluminum Silicate, Carbomer, Ethelyne 
Brassylate, Triethanolamine, Disodium EDTA, Phenoxyethanol, 
Methylparaben, Propylparaben, and Titanium Dioxide. 
 Prior to LP, the cream will be removed by clinic staff and the skin will be 
prepped in the usual sterile fashion. The practitioner performing the LP and 
the physician sedating the patient will be blinded.  
 Patients mature enough to comply will be positioned appropriately and have 
their skin sterilized before propofol is administered. For patients not able to do 
this, propofol will be administered when the patient is in a supine position on 
the bed, or in their parent’s laps or arms (at the discretion of the sedationist). 
 Sedation will be provided following a standardized protocol including 
fentanyl (1mcg/kg) and propofol (2mg/kg). Additional 1 mg/kg doses of 
propofol will be administered at the discretion of the physician performing the 
sedation based on the patients’ movement, pain, vital signs, and oxygen 
saturation. 
 Lumbar punctures will be performed by experienced staff from the Pediatric 
Oncology Clinic (physician, physician assistant, or nurse practitioner). A 22 
gauge needle will be used for every patient. 
 After each sedation, a study staff member will record the data (see Outcome 
measures, below) and survey the practitioners providing sedation and 
performing the LP. 
 Recovery will be the same for all patients. Patients are instructed to lie supine 
or in the Trendelenburg position for at least 20 minutes after each LP. Patients 


5 
 
Version 1   7/19/2012 
who are young or uncooperative may require additional propofol to stay in 
this position, and these instances will be captured (see data collection form).  
 Following recovery, the parent(s) and/or patient will be surveyed as to their 
satisfaction. If a parent does not witness the sedation and procedure, the 
survey will be omitted.  
 
Outcome Measure(s) 
The primary outcome measurements will be the total dose of propofol administered to 
each patient. 
Other outcomes to be measured will include the level of movement at the time of LP 
needle insertion of each patient during the procedure based on the following scale: 
 
1. No movement; no additional propofol was administered. 
 
2. Minor movement; no additional propofol was administered.  
 
3. Major movement; additional propofol was administered.  
 
4. Other: Patient had no or minor movement, but additional propofol was 
administered due to time required to successfully complete the LP (either more 
than one attempt or a prolonged first attempt).  
 
We will also record the height, weight, blood pressure, time and length of the LP; total 
dose of fentanyl administered; time to emergence; length of recovery time; total 
anesthesia time; and practitioner and parent satisfaction surveys. Complications will 
include any change in vital signs that requires intervention by the sedation team, as well 
as post-LP headache and post-LP back pain. Each patient’s parent (and/or the patient) 
will be contacted by telephone within one week of the LP (or in person if the next clinic 
visit is within one week) to ask if the patient had any headache or back pain after the LP, 
and if they had any other complications (Appendix 4). Traumatic LP is defined as an LP 
in which CSF contains at least 10 red blood cells (RBCs) per microliter and bloody LP as 
one in which the cerebrospinal fluid contained at least 500 RBCs per microliter. 
Analytical Plan 
Sedations for which lumbar punctures are unsuccessful will be excluded from analysis. 
Results will be analyzed initially using descriptive statistics.  Raw mean total dose 
administered and raw percentage of times additional propofol was administered will be 
presented by sedation group treating each event (sedation with lumbar puncture) as the 
unit. T-test and chi-square tests will be performed as appropriate for the outcome. 
However, since the events may be correlated within an individual, we will also use 
analyses to take into account the correlated nature. GEE methods will be used when 
analyzing the percentage of times additional propofol was administered. Mixed model 
regression methods will be used when analyzing the total dose administered. 
 
 
 


6 
 
Version 1   7/19/2012 
 
Human Subjects Protection 
 
Subject Recruitment Methods 
The parents of the subjects will be approached for recruitment into the study during their 
Hematology/Oncology clinic visit by the attending Hematologist/Oncologist in a private 
clinic room.  All patients receiving a lumbar puncture through the Hematology/Oncology 
clinic will be approached regardless of race or gender.  
 
Informed Consent 
Signed informed consent and assent (for patients age 7-17 years) will be obtained from 
each subject, who will be identified and approached in the Pediatric Oncology Clinic by 
health care providers in the clinic.   
 
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that 
could directly identify subjects, and maintaining all study information in a secure manner. 
Data and records will be kept locked and secured, with any computer data password 
protected.    The data will be kept secure, with access limited to designated study 
personnel. Following data collection subject identifying information will be destroyed 
.three years after closure of the study by shredding. No reference to any individual 
participant will appear in reports, presentations, or publications that may arise from the 
study.  
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and 
safety of study participants.  The principal investigator will be assisted by other members 
of the study staff. This study will not have a Data Safety Monitoring Board. 
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, serious and unexpected adverse events, deviations or 
protocol changes will be promptly reported by the principal investigator or designated 
member of the research team to the IRB and/or appropriate government agency if 
indicated. 
 
References 
1.  Rappaport B, Mellon RD, Simone A, and Woodcock J. Defining Safe Use of 
Anesthesia in Children. N Engl J Med 2011; 364:1387-1390. 
2. Cravero JP. Risk and safety of pediatric sedation/anesthesia for procedures 
outside the operating room. Current Opinion in Anesthesiology 2009;22:509-13 
3. 3.American Academy of Pediatrics; American Academy of Pediatric Dentistry, 
Coté CJ, Wilson S; Work Group on Sedation. Guidelines for monitoring and 
management of pediatric patients during and after sedation for diagnostic and 
therapeutic procedures: an update. Pediatrics 2006; 118:2587-602 

ICF_000.pdf: 
Version-4 Dated 8-26-2015 
 
 
 
 
 
 
STUDY TITLE: A RANDOMIZED, DOUBLE BLIND TRIAL OF PEDIATRIC LUMBAR 
PUNCTURE UNDER SEDATION/TOTAL INTRAVENOUS ANESTHESIA (TIVA) WITH AND 
WITHOUT EMLA CREAM 
 
Informed Consent Form to Participate in Research 
 
If you are a parent or legal guardian of a child who may take part in this study, 
permission from you is required and the assent (agreement) of your child may be 
required. When we say “you” in this consent form, we mean you or your child; “we” 
means the doctors and other staff. 
 
INTRODUCTION 
You are invited to be in a research study. Research studies are designed to gain scientific 
knowledge that may help other people in the future. You are being asked to take part in 
this study because you are undergoing a lumbar puncture under general anesthesia. Your 
participation is voluntary. Please take your time in making your decision as to whether or 
not you wish to participate. Ask your study doctor or the study staff to explain any words 
or information contained in this informed consent document that you do not understand. 
You may also discuss the study with your friends and family. 
 
WHY IS THIS STUDY BEING DONE? 
You are scheduled to have a lumbar puncture (LP or “spinal tap”). The purpose of this 
research study is to see if a skin numbing cream called EMLA (Eutectic Mixture of Local 
Anesthetic) cream will reduce the amount of total intravenous anesthesia (TIVA) 
(sleeping medicine) needed to effectively perform an LP. There are concerns among the 
anesthesia doctors and scientists about the effect of general anesthesia on patients’ brains, 
especially children’s brains. We would like to find ways to reduce the total amount of 
intravenous anesthesia administered to patients who require sedation for lumbar puncture, 
because giving less IV sleeping medicine is safer than giving more in most 
circumstances. 
 
In this study Eutectic Mixture of a Local Anesthetic (EMLA cream) will be compared to 
placebo cream. A placebo is a substance, like a sugar pill, that is not thought to have any 
effect on your disease or condition. In this study you will either receive the active study 
medication (EMLA cream) or placebo cream which is not active. Placebos are used in 
research studies to see if the drug being studied really does have an effect. 
 
Department of Pediatrics 


Version-4 Dated 8-26-2015 
 
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY? 
Approximately 40 people will take part in this study at a single institution: Wake Forest 
Baptist Medical Center in Winston-Salem, North Carolina.  
 
WHAT IS INVOLVED IN THE STUDY? 
If you agree to participate and sign the forms, at your study visit you will be randomized 
into one of the study groups described below. Randomization means that you are put into 
a group by chance. It is like flipping a coin. You will have an equal chance of being 
placed in each group.  
Neither you nor the investigator will know which cream (EMLA or placebo) you are 
receiving. This is done so that a fair evaluation of results can be made. This information 
is available to the researchers if needed in an emergency. 
 
If you decide to participate in the study, you will only be consented once. You may, 
however, undergo randomization as many times as you are having an LP done. That 
means you sometimes might get the placebo cream and sometimes might get EMLA 
cream. Each LP will require a separate randomization.  You will not be asked to consent 
for the study at each clinic visit. You may stop participating at any time. You may also 
choose to participate in the randomization process for some LPs but not others. The 
choice is yours. 
 
Treatment Group 
If you are randomized into the treatment group, EMLA cream will be placed on your 
lower back and covered with a tape-like dressing when you arrive in clinic. You will then 
be seen in the hematology/oncology clinic as you normally are before going to the 
sedation suite for the lumbar puncture. Once in the sedation suite, the EMLA cream will 
be removed and your lower back will be cleaned in a sterile fashion. Next, you will be 
given IV medicines (usually propofol and fentanyl) to put you to sleep in order to 
effectively perform the lumbar puncture and administer intrathecal chemotherapy with 
little to no movement. The first doses of medicines are based on your weight, but 
additional doses may need to be given if you are moving too much during the LP. This is 
decided by the doctor performing the sedation, often together with the person doing the 
LP. During the time that you are asleep, your vital signs will be monitored and oxygen 
will be provided. Once the procedure has been performed you will be allowed to wake up 
on your own.  
 
Placebo Group 
If you are randomized into the placebo group, everything will be the same except placebo 
(fake) cream will be used instead of real EMLA cream. Placebo cream will be placed on 
your lower back and covered with a tape-like dressing when you arrive in clinic. You will 
then be seen in the hematology/oncology clinic as you normally are before going to the 
sedation suite for the lumbar puncture. Once in the sedation suite, the placebo cream will 
be removed and your lower back will be cleaned in a sterile fashion. Next, you will be 
given a dose of IV medicines (usually propofol and fentanyl) to put you to sleep in order  
 
to effectively perform the lumbar puncture and administer intrathecal chemotherapy with 


Version-4 Dated 8-26-2015 
 
little to no movement. The first doses of medicines are based on your weight, but 
additional doses may need to be given if you are moving too much during the LP. This is 
decided by the doctor performing the sedation, often together with the person doing the 
LP.  During the time that you are asleep, your vital signs will be monitored and oxygen 
will be provided. Once the procedure has been performed you will be allowed to wake up 
on your own.  
 
For both groups, you will also be asked to complete a brief survey after each lumbar 
puncture to see if you/your parent(s) were satisfied with the sedation.  
 
Your treatment for your disease or condition will not change. The schedule and doses of 
chemotherapy you receive (if applicable) will be the same whether you are on this study 
or not. You will be consented separately for the lumbar puncture to administer intrathecal 
chemotherapy.  You will also be consented separately for the sedation that you will 
undergo as you normally would. 
 
WHAT IS THE STANDARD OF CARE FOR LUMBAR PUNCTURES? 
There is not a widely agreed standard of care for lumbar punctures (LPs). Some patients 
have LPs with no sedation and use local numbing medicine (injected into the skin). Some 
patients (including most children) require sedation for LPs. Some doctor’s use EMLA 
cream and some do not. There has never been a study that shows that EMLA cream can 
reduce the amount of anesthesia medicine used for sedation. 
 
How Long Will I Be in the Study? 
You will be in the study for only as long as you wish. It could be as short as one day or as 
long as three years. One randomization and lumbar puncture occurs in one day. You may 
choose to have more LPs on study after the first one, or you may choose to stop being in 
the study after the first LP. Most patients with ALL receive about 20 LPs spaced out over 
2.5 - 3 years. After that, you will no longer receive protocol therapy but you will still be 
in the study. Any research information collected from you in this study will be kept in the 
research records for at least six years after the study is finished. 
 
You can stop participating at any time. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential 
health or safety consequences.  
 
 
WHAT ARE THE RISKS OF THE STUDY? 
Being in this study involves some risk to you. You should discuss the risk of being in this 
study with the study staff. Risks and side effects related to the EMLA cream are: 
 
Common: 
 
 
-Rash or Blanching of the skin 
 
Rare: 


Version-4 Dated 8-26-2015 
 
 
-Methemoglobinemia - decreased ability of the blood to carry oxygen 
-Anaphylaxis or Allergic reaction  
 
There also may be other side effects that we cannot predict. You should tell the research 
staff about all the medications, vitamins and supplements you take and any medical 
conditions you have. This may help avoid side effects, interactions and other risks. 
 
The amount of propofol given to each group will be monitored and recorded by the study 
team. This amount will be increased if there are signs that your child is not receiving 
adequate sedation.  However, your child will never be given a dose that is outside the 
medical guidelines for safety of this drug. 
 
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research 
records secure and allowing only authorized people to have access to research records, 
will be made to keep your information safe. 
 
 
ARE THERE BENEFITS TO TAKING PART IN THE STUDY? 
Based on experience with EMLA cream in other patients, researchers believe it may be of 
benefit to subjects undergoing lumbar puncture. It is possible that EMLA cream could 
allow less IV anesthesia medicine to be used to keep you still for the LP. Getting less IV 
medicine is probably safer than getting more. Because individuals respond differently to 
therapy, no one can know in advance if it will be helpful in your particular case. You are 
not expected to receive any other direct benefits from taking part in this research study. 
We hope the information learned from this study will benefit other people in the future. 
 
 
WHAT OTHER CHOICES ARE THERE? 
You do not have to be in this study to receive treatment. You should talk to your doctor 
about all the choices you have. Instead of being in this study, your options include: 
1. You can choose to have your regularly scheduled lumbar punctures with or without 
EMLA cream while under sedation in the sedation suite. 
2. You can choose to have the lumbar puncture performed without sedation, with or 
without EMLA cream on the lower back.  
 
 
What About My Health Information? 
In this research study, any new information we collect from you about your health or 
behaviors is considered Protected Health Information. The information we will collect for 
this research study includes:  
1. Total dose of propofol administered to you. 
2. Blood pressure during the sedation 
3. Amount of movement if any during the sedation. 
4. Satisfaction with the sedation. 


Version-4 Dated 8-26-2015 
 
5. How long it takes you to wake up. 
6. Anesthesia time and procedure time. 
 
We will make every effort to keep your Protected Health Information private. We will 
store records of your Protected Health Information in a cabinet in a locked office or on a 
password protected computer. Only the following people or organizations will be granted 
access to your Protected Health Information: 
 
1) The study investigator and his team, or others at Wake Forest Baptist Health who 
oversee research 
2) Other people or laboratories providing services for this research project on behalf 
of Wake Forest Baptist Health.  
If required by law or court order, we might also have to share your Protected Health 
Information with a judge, law enforcement officer, government agencies, or others. If 
your Protected Health Information is shared with any of these groups it might no longer 
be protected by federal or state privacy rules. 
 
Any Protected Health Information entered into your medical record will be kept for as 
long as your medical record is kept by the Medical Center.  Any research information 
collected from you in this study will be kept in the research records for at least six years 
after the study is finished. At that time any research information not already in your 
medical record will either be destroyed or it will be de-identified. You will not be able to 
obtain a copy of your research records until all activities in the study are completely 
finished. 
 
You can tell Dr. Thomas McLean, MD that you want to take away your permission to use 
and share your Protected Health Information or research information at any time by 
sending a letter to this address: 
 
Dr. Thomas McLean, MD 
Department of Pediatrics  
Medical Center Blvd 
Winston-Salem, NC 27157 
 
However, if you take away permission to use your Protected Health Information you will 
not be able to be in the study any longer. We will stop collecting any more information 
about you, but any information we have already collected can still be used for the 
purposes of the research study. 
By signing this form you give us permission to use your Protected Health Information for 
this study. 
 
If you choose to participate in this study, your medical record at Wake Forest University 
Baptist Medical Center will indicate that you are enrolled in a clinical trial.  Information 
about the research and any medications or devices you are being given as a participant 
may also be included in a special section of your medical record.  This part of the medical 


Version-4 Dated 8-26-2015 
 
record will only be available to people involved in the research study or persons treating 
you at this Medical Center.   
 
Information about this clinical trial will be placed in the clinical trial registry maintained 
by the National Institutes of Health/National Library of Medicine (NIH/NLM). 
 
Laboratory test results and other medical reports created as a result of your participation 
in the research study may be entered into the computer systems of Wake Forest 
University Health Sciences and North Carolina Baptist Hospital.  These will be kept 
secure, with access to this information limited to individuals with proper authority, but 
who may not be directly involved with this research study. 
 
This authorization is valid for six years or five years after the completion of the study, 
whichever is longer. 
  
 
What Are the Costs?  
There are no costs to you for taking part in this study. If you are randomized to receive 
EMLA cream, it will be billed to your insurance as it usually is. Insurance virtually 
always covers the cost of EMLA cream for children having invasive procedures. If you 
do not have insurance, please let your doctor know and EMLA cream will be provided 
free of charge. All other costs, including any study medications and procedures related 
directly to the study, will be paid for by the study. Costs for your regular medical care, 
which are not related to this study, will be your own responsibility. 
 
 
WILL YOU BE PAID FOR PARTICIPATING? 
There are no plans to pay you for taking part in this study. 
 
 
What Happens if You Experience an Injury or Illness as a 
Result of Participating in this Study? 
Should you experience a physical injury or illness as a direct result of your participation 
in this study, Wake Forest University School of Medicine maintains limited research 
insurance coverage for the usual and customary medical fees for reasonable and 
necessary treatment of such injuries or illnesses. To the extent research insurance 
coverage is available under this policy the reasonable costs of these necessary medical 
services will be paid, up to a maximum of $25,000. Wake Forest University Baptist 
Medical Center holds the insurance policy for this coverage. It provides a maximum of 
$25,000 coverage for each claim and is limited to a total of $250,000 for all claims in any 
one year. The Wake Forest University School of Medicine, and the North Carolina 
Baptist Hospitals, Incorporated do not assume responsibility to pay for these medical 
services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management. 
 
If you are injured, the insurer may require information such as your name, social security 


Version-4 Dated 8-26-2015 
 
number, and date of birth in order to pay for your care.  This is because the insurer is 
required by law to report any payments made to cover the care of any persons who are 
members of a government insurance plan to the Department of Health and Human 
Services. 
 
You do not give up any legal rights as a research participant by signing this consent form. 
For more information on medical treatment for research related injuries or to report a 
study related illness, adverse event, or injury you should call Dr. Thomas McLean. 
 
 
WHAT ARE MY RIGHTS AS A RESEARCH STUDY PARTICIPANT? 
Taking part in this study is voluntary. You may choose not to take part or you may leave 
the study at any time. Refusing to participate or leaving the study will not result in any 
penalty or loss of benefits to which you are entitled. If you decide to stop participating in 
the study we encourage you to talk to the investigators or study staff first to learn about 
any potential health or safety consequences. The investigators also have the right to stop 
your participation in the study at any time. This could be because it is in your best 
medical interest, your condition worsened, new information becomes available, you had 
an unexpected reaction, or because the entire study has been stopped.  
 
You will be given any new information we become aware of that would affect your 
willingness to continue to participate in the study. 
 
 
Whom Do I Call if I Have Questions or Problems? 
For questions about the study or in the event of a research-related injury, contact the 
study investigator 
 
The Institutional Review Board (IRB) is a group of people who review the research to 
protect your rights. If you have a question about your rights as a research participant, or 
you would like to discuss problems or concerns, have questions or want to offer input, or 
you want to obtain additional information, you should contact the Chairman of the IRB. 
 
You will be given a copy of this signed consent form.  
 
 
 
 
 
 
 
 
SIGNATURES 
 
 
I agree to take part in this study. I authorize the use and disclosure of my health 


Version-4 Dated 8-26-2015 
 
information as described in this consent and authorization form.  If I have not already 
received a copy of the Privacy Notice, I may request one or one will be made available to 
me.  I have had a chance to ask questions about being in this study and have those 
questions answered.   By signing this consent and authorization form, I am not releasing 
or agreeing to release the investigator, the sponsor, the institution or its agents from 
liability for negligence. 
 
 
                                                                                         
Signature of Subject/ Parent/Legal Guardian                Date:               Time:         am/pm
 
 
 
 
Printed Name of Subject/ Parent/Legal Guardian 
 
 
                                                                                       
Name of Child in the study 
 
   
                                                                                       
Legal Guardian’s Relationship to Child in study 
 
  
                                                                                       
Signature of Person Obtaining Consent 
 
   Date:                Time:         am/pm