Clinical trial NCT04551196
Conditions: Pain, Postoperative Tonsillar Hypertrophy Tonsillitis
Sponsor: Washington University School of Medicine
Start date: 2020-09-28; Completion date: 2022-11-10
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the pediatric population. 100 children undergoing tonsillectomy will be randomized to receive either a combined acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and ibuprofen dosed every 3 hours.

Detailed description:

Arms: arm 1: A regimen of acetaminophen and ibuprofen alternating doses every 3 hours. arm 2: A regimen of acetaminophen and ibuprofen dosed together every 6 hours.
Interventions: intervention 1: Alternating Acetaminophen and Ibuprofen intervention 2: Combined Acetaminophen and Ibuprofen
Intervention descriptions: intervention 1: Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours. intervention 2: Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.

Protocol documents:
Prot_SAP_ICF_005.pdf: 
CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
RESEARCH PROTOCOL 
 
 
Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for Management of 
Post-Tonsillectomy Pain in Pediatric Patients  
 
 
 
 
 
Shahroz Fatima, BS 
Washington University School of Medicine 
shahrozfatima@wustl.edu 
 
Alan Hifko, MD 
Clinical Research Coordinator 
Division of Clinical and Translational Research 
Department of Anesthesiology 
Ahifko@anest.wustl.edu 
 
David S. Leonard, MBBCh 
Pediatric Otolaryngology 
dsleonard@wustl.edu 
 
Michael C. Montana, MD, PhD 
Pediatric Anesthesiology 
montana@wustl.edu 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version 2 
January 26, 2020 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
Study Title 
 
 
Effectiveness of Combined Acetaminophen and Ibuprofen Regimen for Management of Post-
Tonsillectomy Pain in Pediatric Patients 
Objectives 
To compare the effectiveness of a combined regimen of acetaminophen and ibuprofen dosed every 6 hours 
with the current practice of alternating acetaminophen and ibuprofen every 3 hours in the treatment of post-
operative tonsillectomy pain in the pediatric population. 
Study Period 
1 year 
Number of 
Subjects 
200 subjects’ ages 4-17 who undergo tonsillectomy with or without adenoidectomy at St. Louis Children’s 
Hospital (SCLH) and the Children’s Specialty Care Center (CSCC). 
Study 
Treatment 
A combined acetaminophen and ibuprofen medication regimen administered every 6 hours following surgery 
through the end of post-operative day (POD) 3 compared against the current practice of alternating 
acetaminophen and ibuprofen every 3 hours following surgery through the end of post-operative day 3. 
Study Design 
Single-center, randomized, open-label, non-inferiority treatment pilot study to evaluate the effectiveness of a 
combined acetaminophen and ibuprofen regimen for treatment of post-operative tonsillectomy pain in the 
pediatric population. 200 children undergoing tonsillectomy will be randomized to receive either a combined 
acetaminophen and ibuprofen regimen dosed every 6 hours or an alternating regimen of acetaminophen and 
ibuprofen dosed every 3 hours.  
Inclusion and 
Exclusion 
Criteria 
Inclusion Criteria 
a) 4 to 17 years of age at time of enrollment 
b) Undergoing tonsillectomy with or without 
adenoidectomy 
c) Able to provide informed consent from parent or 
legal guardian  
d) Able to provide assent if subject is a minor of 
appropriate age 
Exclusion Criteria 
a) Allergy to acetaminophen or ibuprofen 
b) Inability for study participant to cooperate 
with pain assessments 
c) Known pregnancy  
d) Any condition which would make the 
participant, in the opinion of the 
investigator, unsuitable for the study 
Measurements 
Pain scores will be measured in the post-anesthesia care unit (PACU) when first awakening, at 30 minutes, and 
then hourly after PACU arrival, as well as at the time of discharge and prior to administration of rescue 
medication. Safety assessments will be performed as standard of care in the PACU. A medication log will be 
given to subjects to assess their adherence to the study regimen, duration of medication usage, and use of 
break through analgesic medication. Follow up surveys to assess pain scores will be sent to participants twice 
a day on post-operative day (POD) 1, 3, and 7. Pain will be assessed using the standardized FLACC scale for 
all subjects, as well as an additional assessment using the standardized Wong-Baker Faces scale for subjects 
ages 7 and older.  
Outcomes 
Primary:  The proportion of FLACC pain scores ≥7 from POD 1 through POD 3 between the combined and the 
alternating medication regimens 
 
Secondary: (between the combined and the alternating medication regimens) 
1. The proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7 
2. The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7  
3. The proportion of Faces pain scores 8 on POD 1, 3, and 7  
4. The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7  
5. The proportion of rescue medication usage from POD 1 through POD 3  
6. The proportion of rescue medication usage from POD 1 through POD 7  
7. Adherence to the assigned study medication regimen   
8. Incidence of adverse events 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
1. Background and Rationale:  
Tonsillectomy is the 2nd most common outpatient pediatric surgical procedure performed 
in the U.S. with over half a million surgeries annually. The two main primary indications for 
pediatric tonsillectomy are recurrent infections and sleep disordered breathing (SDB)1. 
Tonsillectomy is defined as a surgical procedure performed with or without adenoidectomy that 
completely removes the tonsil, including its capsule, by dissecting the peritonsillar space between 
the tonsil capsule and muscular wall1. They are relatively low risk surgical procedures usually 
done as a same-day surgery2. The Royal College of Surgeons of England found that 
tonsillectomies had a delayed discharge rate of 1.9 % due to various reasons, including post-op 
pain, hemorrhage, respiratory complications, and vomiting. The top reason for these delays was 
inadequate pain control accounting for 36% of delayed discharges 3. Acute pain can cause stress, 
fear, and anxiety for both the patient and the caregiver 4. Furthermore, it is also associated with 
poor oral intake, vomiting, and sleep disturbances for the patient 5.  Thus, adequate post-op pain 
control is an essential component to ensuring timely healing and patient well-being following 
surgery. Additionally, according to prior research done on adult tonsillectomy patients, the 
incidence of severe pain, defined as pain ≥7 on a 10-point scale, is 14.5% on post-op Day 1, 
39.9% on Day 3, 28.4% on Day 7 6.  
One of the most widely used drugs for post-operative pain relief in tonsillectomy prior to 
2013 was codeine. Codeine is a prodrug that is metabolized to morphine via the CYP2D6 
enzyme, providing an oral form of pain control that was thought to have a good safety profile 7. 
However, recent research has found significant genetic variability in this enzyme, where poor 
metabolizers get little or no pain relief while ultra-rapid metabolizers are at high risk for 
respiratory depression 8. Although genetic testing for CYP2D6 exists, it is expensive, and 
normal metabolizers may still experience adverse effects. In 2013, the FDA issued a “black box 
warning” for codeine, advising health care professionals “to prescribe an alternative analgesic 
for postoperative pain control in children” 8. Furthermore, a randomized trial in SDB patients 
undergoing tonsillectomy found that the number of desaturation events per hour (preoperative to 
postoperative) was reduced by a mean of 1.79 ± 7.57 in the group given ibuprofen compared 
with an average increase of 11.17 ± 15.02 in the morphine group 9. Thus, identifying the best 
alternatives to opioids for post op pain control for pediatric tonsillectomy patients are critical.  
The main alternatives are acetaminophen and NSAIDs. Scheduled acetaminophen is the 
recommended first line treatment for post op pain relief following discharge from the hospital 10. 
However, to ensure adequate pain control, acetaminophen is generally used in conjunction with 
other drugs, namely opioids 1 However, a potential alternative to opioids are NSAIDs. NSAIDs 
were initially avoided due to the potential increased risk of bleeding and hemorrhage when 
compared to opioids 11. However, this conflicts with a recent Cochrane review of 900 patients 
from various RCTs that demonstrated no increased risk of bleeding with NSAIDs use in post-
tonsillectomy patients compared to patient that did not receive NSAIDs 12. Thus, the current 
guidelines from the American Academy of Otolaryngology-Head and Neck surgery recommend 
the use of NSAIDs alongside acetaminophen for post-tonsillectomy pain relief1. A recent trial in 
adults compared a combined acetaminophen+ ibuprofen regimen against only acetaminophen 
or only ibuprofen and found that the combined regimen had improved pain control 13. This 
suggests that a combined regimen may be superior to a single non-opioid analgesic strategy. 
Furthermore, there is also evidence of potential synergistic effects when the 2 drugs are given 
at the same time 14. Some otolaryngologists at SLCH currently advise their patients to take 
acetaminophen and ibuprofen on an alternating basis, with one drug administered every 3 
hours, but each drug only given every 6 hours. This is done on the belief that more frequent 
analgesic dosing will provide superior pain control. However, this practice has never been 
compared directly to giving both drugs simultaneous every 6 hours.  
Necessary caretaker involvement in the pediatric population adds a new layer of 
complexity to medication dosing. Adhering to various, often confusing or tedious, pain control 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
regimens post-operatively can be a challenge for caregivers who are balancing many other 
aspects of life while caring for the child. This is especially true for families with caregivers who 
are working and cannot always be available around the clock to give frequent scheduled pain 
medication. Furthermore, despite various oral formulations, children do not enjoy taking 
medications, which can further frustrate caretakers. The American Academy of Family 
Physicians notes these limitations and suggests having a simplified regimen to assist patients 
and families in adhering to the medication regiment  15. Thus, we aim to assess a means to limit 
this confusion while also assessing pain control and patient satisfaction. We will compare a 
combined regimen where both acetaminophen and ibuprofen are administered together every 6 
hours, with a regimen that is currently practiced at St. Louis Children’s Hospital where 
acetaminophen and ibuprofen are alternated, one medication given every three hours. There is 
currently a dearth of information regarding adherence to medication regimens and we hope our 
study will help elucidate a more convenient regimen with equal or improved pain control to a 
more tedious current standard pain control regimen 16.  
In this study, we will compare the common post-tonsillectomy pediatric pain regimen of 
alternating acetaminophen and ibuprofen every three hours with a regimen in which a patient is 
given both medications every 6 hours. Since the black box warning placed on codeine, there 
has been no one standard of care, for post-tonsillectomy pain. We hope that this study will 
provide objective data regarding optimal pain control for this patient population. 
 
2. Objectives 
The goal of this research proposal is to assess the effectiveness of two dosing regimens in 
controlling post-tonsillectomy pain in pediatric populations. We aim to assess how a combined 
scheduled dosing regimen of acetaminophen and ibuprofen every 6 hours compares with the 
dosing regimen currently used at SLCH of alternating acetaminophen and ibuprofen every 3 
hours. We hope to show that a combined regimen is non-inferior in terms of instances of severe 
pain experienced by patients following hospital discharge, and/or in need for rescue pain 
medication to the alternating regimen.  
In addition, we believe that based on the current guidelines for pediatric post-tonsillectomy 
pain control, the simultaneous administration of acetaminophen and ibuprofen may play a 
significant role in improving patient satisfaction and compliance. This regimen was relatively well 
tolerated with minimal adverse events reported in adults undergoing dental surgery 13. A recent 
double-blind study performed in adults following wisdom teeth removal showed improved pain 
control with a combined regimen when compared to either acetaminophen or ibuprofen alone13. 
However, there is a dearth of studies to guide therapy in the pediatric population.  We hope to 
expand on this by introducing a new regimen that may be easier to follow, and will likely improve 
compliance and satisfaction amongst patients and caregivers. Furthermore, there are no studies 
comparing a combined dose of acetaminophen and ibuprofen administered at the same time 
versus an alternating dosing strategy. As the combined dosing strategy is markedly easier for 
families to comply with, if it is non-inferior to the alternating dosing strategy, it would likely be 
preferred.  
This pilot study is the first step in determining both the safety and effectiveness of combined 
pain medication vs. the current practice of alternating each medication regimen following 
tonsillectomy in pediatric populations. It will allow us to assess the degree of difference in both 
pain relief and patient satisfaction while also assessing for any unforeseen adverse outcomes. 
We will use information gleaned here to power and design a larger scale study. 
 
 
 
 
 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
3.  Preliminary Data  
Over the past year from 2017-2018, there were over 700 tonsillectomies and 
adenotonsillectomies performed at St. Louis Children’s Hospital (SLCH) and the ambulatory 
surgery center at the Children’s Specialty Care Center (CSCC). The ages of the patients ranged 
from 1 to 18 and indications included recurrent infections, sleep disordered breathing, and a 
variety of other conditions. These numbers illustrate the feasibility of conducting a study of 100 
patients in a reasonable time frame, ideally in less than 1 year.  
 
4. Patient Selection  
Subjects will be recruited through the St. Louis Children’s Hospital (SLCH) Otolaryngology 
Department. Subjects will be approached prior to surgery in person. Prior to study initiation written 
informed consent will be obtained from subjects’ parent or legal guardian, and assent will be 
obtained from minors of appropriate age. Goal enrollment is 200 children (4-17 years old) who 
are undergoing tonsillectomy with or without adenoidectomy.  
 
4.1. Inclusion Criteria 
4.1.1. 4 to 17 years of age at time of enrollment  
4.1.2. Undergoing tonsillectomy with or without adenoidectomy 
4.1.3. Able to provide informed consent from parent or legal guardian  
4.1.4. Able to provide assent if subject is a minor of appropriate age 
 
4.2. Exclusion Criteria 
4.2.1. Allergy to acetaminophen or ibuprofen 
4.2.2. Inability for study participant to cooperate with pain assessments  
4.2.3. Known pregnancy 
4.2.4. Any condition which would make the participant, in the opinion of the investigator, 
unsuitable for the study 
 
5. Methods:  
5.1. Study design:  
Single-center, randomized, open-label, non-inferiority pilot study.  
 
5.2 Enrollment 
The  surgery  schedule  at  SLCH  is  posted  in  advance  which allows us to evaluate 
daily for eligible subjects to approach for inclusion. The patients’ medical record will be 
screened for: age of child, type of surgical procedure planned, pertinent medical history, 
whether the child is in the custody of a legal caregiver, and ability to consent/assent to the 
study. Eligible candidates scheduled to undergo tonsillectomy at SLCH will be approached 
either in the outpatient setting or preoperative holding area prior to surgery by a member of the 
study team. Study details will be explained and informed consent obtained from parents or legal 
guardian, and assent as appropriate.  


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
Figure 1. Study Protocol  
 
 
5.3 Treatment phase 
Patients will be randomized to one of two post-operative pain control medication regimens 
through POD 3. Randomization will follow a block randomization with blocks of 10 subjects. To 
maintain allocation concealment the research associate who assigns patients has no knowledge 
of the randomization sequence. The study clinicians will not be blinded, as they will be required 
to write prescriptions and caregivers will not be blinded as they will carry out the assigned 
treatment regimen. Participants will be randomized to either the alternating medication regimen, 
which is the current practice of alternating doses of acetaminophen and ibuprofen every 3 hours 
following surgery through the end of POD 3 or the combined medication regimen, which is a 
combined administration of acetaminophen and ibuprofen every 6 hours following surgery through 
the end of POD 3.  
 
As standard of care, all patients will receive a single dose of intravenous acetaminophen 
intraoperatively which will also serve as time-point 0. The combined treatment group will receive 
the first dose of oral (PO) ibuprofen in the post-anesthesia care unit (PACU) with all subsequent 
doses given as a combination of PO acetaminophen and ibuprofen every 6 hours (with IV 
acetaminophen counting as time-point 0). The alternating treatment group will receive the first 
dose of PO ibuprofen 3 hours after the intra-operative IV acetaminophen. All subsequent doses 
of alternating PO acetaminophen and ibuprofen will be given on an alternating basis, every 3 
hours.  


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
 Figure 2. Pain medication regimens for each arm of the study.  
  
Post operatively pain scores will be measured in the PACU when first awakening, at 30 
minutes, and then hourly after PACU arrival, as well as at the time of discharge and prior to 
administration of rescue medication. Safety assessments will be performed as standard of care 
in the PACU. Follow up surveys to assess pain scores will be sent to participants twice a day on 
POD 1, 3, and 7. In the event a participant doesn’t have an email address or access to a 
smartphone or computer, they will be sent home with a copy of the surveys and the study team 
will call them to obtain the responses.  Pain will be assessed using the standardized FLACC scale 
for all subjects, as well as an additional assessment using the standardized Wong-Baker Faces 
scale for subjects ages 7 and older. Note that the day of surgery is post-operative day 0. Pain 
assessment surveys will be sent electronically to participants via Redcap or completed through 
the MyCap app on their smartphone. Participants will be given the option to utilize MyCap to 
receive their follow up surveys. Mycap is a mobile phone application that allows research 
participants to report outcomes directly to a REDCap database using their personal mobile phone 
or tablet. A traditional REDCap database is utilized to setup the data collection instruments and 
store study data. MyCap translates the defined REDCap instruments into a format compatible 
with Android or IOS devices and allows participants to complete them from their mobile device. 
Once a task is completed, MyCap converts the results into a format compatible with REDCap 
before synchronizing back to the REDCap database. Perceived likeability of the assigned 
medication regimen will be assessed on POD 3 using a 7 point Likert scale.  
 
Orders and prescriptions for medication will be provided by the operating surgeons. 
Patients who are admitted post operatively will have their medication regimen administered by 
hospital nursing staff until their discharge. The timing of these medications and any breakthrough 
analgesic medications will be obtained from the patient’s electronic medical record. Upon 
discharge, the timing of acetaminophen and ibuprofen, and the use of any break through 
analgesic medication will be recorded by caregivers in a paper journal provided by the study team. 
Upon completion of the study regimen, at the end of POD 3, caregivers may continue to provide 
analgesic medications as needed using whichever regimen they prefer. We will continue to collect 
medication usage, and pain scores through POD 7 regardless of medication timing after POD 3.  
 
All patients will be prescribed a rescue analgesic medication, oxycodone, for breakthrough 
pain relief as needed. Caregivers will be provided with a copy of the FLACC criteria, and Wong-
Baker Faces scoring criteria if the subject is 7 years of age or older, as well as instructions on 
how to properly score on the 2 different scales.  
 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
 
Figure 3. FLACC scale  
https://www.researchgate.net/publication/283575369_Physicians'_use_of_pain_scale_and_treatment_proce
dures_among_children_and_youth_in_emergency_primary_care_-_a_cross_sectional_study 
 
 
 
 
Figure 4. Wong-Baker Faces scale via the Wong-Baker Faces Foundation 
https://wongbakerfaces.org/ 
 
 
 
 
Figure 5. Likert Scale 
 
 
 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
5.4. Conclusion of study 
The study period for each subject ends once all surveys are submitted. The total time 
spent per subject for this study will be approximately 8 days.  
 
6.  Data Collection and Monitoring 
6.1. Demographic Data  
After consent is obtained we will collect basic demographic information (age, race, 
gender), indication for tonsillectomy, surgical technique, and pertinent medical history.  
 
6.2. Clinical Assessments 
Prior to pain medication administration the patient will undergo a focused history and 
physical exam performed by a member of the research team to check contraindications to the 
proposed medications.  
 
6.3 Pain Assessments  
Post operatively pain scores and safety assessments will be measured in the PACU upon 
awakening, prior to administration of any rescue medications, and prior to discharge. Following 
discharge from the hospital, each study participant’s caregiver will receive online surveys to 
complete twice a day (12 hours apart) on POD 1, 3, and 7. Caregivers will be requested to 
complete one survey between 6am and 9am and another survey between 6pm and 9pm. Surveys 
will be distributed via Redcap. They will evaluate and record the following information prior to the 
administration of the morning and evening medications that day:  
 
1) Patient’s Faces, Legs, Arms, Cry, Consolability (FLACC) score for all children (Fig. 3) 
2) Patient’s Wong-Baker Faces Pain Scale score for children ages 7 and older (Fig. 4)  
3) Dose in milligrams of rescue pain medication (oxycodone) used in the past 12 hours 
4) Has the patient experienced severe pain >= 7/10 on either scale. (yes or no)  
5) Any adverse events since the surgery or submission of the previous survey 
6) Ease of use of the assigned regimen on the Likert scale rated from very easy to very difficult  
 
6.4 Medication Log 
 
Time and date of medication administration will be obtained from the subjects’ electronic 
medical record during their time in the PACU and for those admitted post operatively. Upon 
discharge a paper medication log will be given to subjects to record the time and date medication 
is administered. This log will be used to assess adherence to the study regimen, duration of 
medication usage, and use of break through medication.   
 
7. Outcome Measures 
7.1 Primary Outcome  
The cumulative proportion of FLACC pain scores ≥7 from POD 1 through POD 3 between the 
combined and the alternating medication regimens 
 
7.2. Secondary Outcome Measures (between the combined and the alternating medication 
regimens) 
7.2.1. The proportion of FLACC pain scores ≥7 on each individual POD 1, 3, and 7 
7.2.2. The proportion of cumulative FLACC pain scores ≥7 from POD 1 through POD 7  
7.2.3. The proportion of Faces pain scores ≥8 on POD 1, 3, and 7  
7.2.4. The proportion of cumulative Faces pain scores ≥8 from POD 1 through POD 7  
7.2.5. The proportion of rescue medication usage from POD 1 through POD 3  
7.2.6. The proportion of rescue medication usage from POD 1 through POD 7  
7.2.7. Adherence to the assigned study medication  


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
7.2.8. All adverse events including but not limited to presenting to the emergency department for 
severe bleeding, anorexia, or intractable nausea or vomiting. 
 
7.3 Exploratory Outcome Measures 
7.3.1. Comparison of pain scores in patients over versus under the age of 12 
Perception of pain and the expression of pain vary considerably amongst older and 
younger patients. The FLACC scale in particular, has components such as crying and body 
movements that may not entirely reflect the expression of pain in older children in particular. Thus 
in order to account for this difference, we would like to conduct a separate analysis for children 
above and below the age of 12 to ensure there are no significant differences between the groups, 
If there are significant differences, we will report those in a stratified analysis. 
7.3.2. Comparison of pain scores based on surgical technique 
Surgical technique for tonsillectomy can be divided into 3 major categories: cold 
dissection, electrocautery, and harmonic scalpel tonsillectomy. The cold knife method removes 
the tonsils by use of a standard scalpel and is the most common procedure. The electrocautery 
method burns tonsillar tissue and assists with bleeding, but causes thermal injury to surrounding 
tissue. Studies show that although bleeding was significantly lower, pain intensity at 4 and 24 
hours post-surgery was significantly higher17. Finally, the Harmonic scalpel uses ultrasonic energy 
to vibrate the blade, which results in simultaneous cutting and couterizing18. Previous studies have 
shown that the use of the Harmonic scalpel during surgery reduces both the volume of intra-
operative bleeding and pain intensity level on postoperative day one19. Thus given these findings, 
surgical technique is a potential confounder in the study which we will account for by doing a 
stratified subgroup analysis to detect any strata specific differences. 
 
7.4. Analysis 
This is a non-inferiority pilot study comparing the proportion of patients with severe pain 
(FLACC score≥7) in the combined regimen vs. the alternating regimen. Our null hypothesis is that 
the combined regimen is inferior to the currently used alternating regimen and our alternative 
hypothesis is that it is non-inferior. Based on clinical judgment, the margin within which we will 
consider the proposed combined dosing regimen to be similar in effectiveness to the current 
clinical practice of an alternating regimen is 0.15. Based on prior studies in adult tonsillectomy 
patients using a 10-point scale, the incidence of severe pain (≥7) on  post-op Day 1 is 0.145, Day 
3 is 0.399, and Day 7 is 0.284, with a final total proportion of pain ≥7 divided by total pain scores 
collected of 0.1946. There is no data analyzing these proportions with our proposed combined 
regimen as it is a novel medication regimen not used before. 
Pain between POD 1 and POD 3 was chosen as the primary outcome because prior 
research has indicated POD 3 to be the day with most severe pain in adults6. In order to obtain 
this proportion, we will first convert FLACC pain scores (graded on a 10 point scale) into a binary 
outcome: those with severe pain (scores ≥7) and those without severe pain (scores ≤ 7). We 
chose 7 as pain scores ≥7 are considered to be “severe” based on prior studies6,17. In addition to 
providing current pain assessments, caregivers will also be asked whether or not their child had 
severe pain since they left the hospital (first survey) or since they last filled out a previous survey 
(all other surveys).  
 
As this is a pilot study, we based our sample size on 2018-2019 hospital data which 
revealed that over 700 pediatric tonsillectomies +/- adenoidectomies were conducted at the St. 
Louis Children’s Hospital and Children’s Specialty Care Center combined. Thus we plan to 
approach and recruit at least 100 patients for our study. The secondary outcome measures are 
the proportion of patients with severe pain (FLACC score ≥7), the average use of breakthrough 
pain medication, and all adverse events. Thus, if the hypothesis is correct, we anticipate no 
significant difference with using the alternating versus combined pain regimen in pediatric patients 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
undergoing tonsillectomy. We hope that these findings will allow for a more simplified pain 
regimen with ease of use amongst caregivers.    
 
8.  Potential Risks 
8.1. Breach of confidentiality 
 
There is minimal risk associated with the collection and recording of patient medical record 
numbers to permit review of the patient’s medical record. 
 
MyCap App Security: 
Participant data is stored locally on the device in an AES-256+SHA2 encrypted database. Data 
remains on the device if an internet connection is not available. Applies to both iOS and Android 
devices. 
 
When an internet connection is available, data is transmitted to REDCap using an SSL 
connection. A hash-based message authentication code (HMAC) is used to verify the integrity of 
the data and to authenticate the sender. 
 
Data is deleted from the device after the MyCap app verifies that data has been successfully 
transmitted.  
 
Authentication to Device: 
Participants create a 6-digit PIN that is used to open the MyCap, this is in addition to the 
authentication already on their device. 
 
8.2. Combined acetaminophen and ibuprofen risk 
 
There is minimal risk associated with either acetaminophen or ibuprofen. The American 
Academy of Otolaryngology-Head and Neck Surgery Foundation makes a strong 
recommendation that “clinicians should recommend ibuprofen, acetaminophen, or both for pain 
control after tonsillectomy.”1  
 
8.3 Steps Taken to Mitigate Risk 
Studies are conducted under the supervision of the investigating physicians who are 
trained and experienced in performing research in human subjects, and in monitoring local 
anesthetic related adverse effects.  
Inclusion and exclusion criteria, monitoring, and the clinical protocol are designed to 
ensure that risks are minimal. Subjects are informed that participation is voluntary and they may 
refuse to participate and may withdraw from the study at any time without penalty. A pregnancy 
test will be performed on women of childbearing potential, as is standard of care, and subjects 
excluded if pregnant. Subjects will be told that in the event of a physical injury as the direct result 
of study procedures, they will be cared for by a member of the investigating team at no cost, within 
the limits of the Washington University compensation plan. 
The first dose of both regimens will be administered while the patient is in the post-
operative recovery area with monitoring for any adverse effects. If the patient is unable to tolerate 
the treatment they may request to be removed from the study or may be removed by the principle 
investigator if they are unable to complete the study. 
Regarding confidentiality; 1) all subjects will be assigned a study ID number, 2) The link 
to identifiers will be destroyed at the end of the study. 3) Data will be stored under lock and key 
(office, file cabinet) and only the investigators and research team will have access. If data are 
published, there will be no link to identifiers. Study data will not be revealed to any organization, 
individuals other than the subjects, or the subjects themselves. 4) Study data will not be entered 
in subjects' medical records.  


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
 
9. Management of Intercurrent Events 
9.1. Adverse Experiences 
The investigator will closely monitor subjects for evidence of adverse events.  All adverse 
events will be reported and followed until satisfactory resolution.  The description of the adverse 
experience will include the time of onset, duration, intensity, etiology, relationship to the study 
drug (none, unlikely, possible, probable, highly probable), and any treatment required. 
 
9.2. Premature Discontinuation 
If a subject withdraws from the study, the subject will be replaced to provide the required 
number of subjects. Subjects will be withdrawn if the investigator decides that discontinuation is 
in the best interest of the subject, or the subject requests withdrawal from the study. 
 
 
 
 
10.  Data and Safety Monitoring Plan 
Studies conducted in the Department of Anesthesiology follow the Washington University 
Institutional Review Board Policies and Procedures (last revision January 21, 2019). All 
individuals working on the study are required to read and be familiar with and compliant with the 
IRB Policies and Procedures. The specific monitoring plan for this investigation is commensurate 
with the risks and the size and complexity of the investigations planned. The potential risks are 
attributable to the use of ibuprofen and acetaminophen. Based on the small size and relatively 
low risk nature of the protocol, the investigating physicians are involved in the monitoring plan. A 
full DSMB is not needed. These individuals will review the annual summary of adverse events. In 
addition, they will review all reports of a Serious Adverse Event, or an Unexpected Adverse Event. 
The investigators will follow the requirements for principle investigator reporting requirements as 
outlined in Section X of the IRB Policies and Procedures.   
 
 
References: 
1. Mitchell, R. B. et al. Clinical Practice Guideline: Tonsillectomy in Children (Update). Otolaryngol. 
Neck Surg. 160, S1–S42 (2019). 
2. Ingram, D. G. & Friedman, N. R. Toward Adenotonsillectomy in Children: A Review for the General 
Pediatrician. JAMA Pediatr. 169, 1155–1161 (2015). 
3. National Prospective Tonsillectomy Audit Final Report. Royal College of Surgeons 
https://www.rcseng.ac.uk/library-and-publications/rcs-publications/docs/tonsillectomy-audit/. 
4. Power, N. M. et al. Correspondence to. (2012). 
5. Stanko, D., Bergesio, R., Davies, K., Hegarty, M. & von Ungern-Sternberg, B. S. Postoperative pain, 
nausea and vomiting following adeno-tonsillectomy - a long-term follow-up. Paediatr. Anaesth. 23, 
690–696 (2013). 
6. Álvarez Palacios, I., González-Orús Álvarez-Morujo, R., Alonso Martínez, C., Ayala Mejías, A. & 
Arenas Brítez, O. Postoperative Pain in Adult Tonsillectomy: Is There Any Difference Between the 
Technique? Indian J. Otolaryngol. Head Neck Surg. 69, 187–193 (2017). 
7. Lauder, G. & Emmott, A. Confronting the challenges of effective pain management in children 
following tonsillectomy. Int. J. Pediatr. Otorhinolaryngol. 78, 1813–1827 (2014). 
8. Tobias, J. D., Green, T. P., Coté, C. J., Medicine, S. on A. and P. & Drugs, C. O. Codeine: Time to 
Say “No”. Pediatrics 138, e20162396 (2016). 
9. Kelly, L. E. et al. Morphine or Ibuprofen for Post-Tonsillectomy Analgesia: A Randomized Trial. 
Pediatrics 135, 307–313 (2015). 


CONFIDENTIAL: This document is the intellectual property of Michael Montana, MD, PhD, David S. Leonard, MD, Alan 
Hifko, MD, and Shahroz Fatima, BS. Acceptance of this document constitutes the agreement by the recipient that not 
unpublished information contained herein will be published or disclosed without prior written approval.  
10. Ismail Zaidan & Amanda Lent. Post-Tonsillectomy Pain in Children: The Postcodeine Era. US 
Pharm. 41, 31–34 (2016). 
11. D’Souza, J. N., Schmidt, R. J., Xie, L., Adelman, J. P. & Nardone, H. C. Postoperative nonsteroidal 
anti-inflammatory drugs and risk of bleeding in pediatric intracapsular tonsillectomy. Int. J. Pediatr. 
Otorhinolaryngol. 79, 1472–1476 (2015). 
12. Lewis, S. R., Nicholson, A., Cardwell, M. E., Siviter, G. & Smith, A. F. Nonsteroidal anti‐
inflammatory drugs and perioperative bleeding in paediatric tonsillectomy. Cochrane Database Syst. 
Rev. (2013) doi:10.1002/14651858.CD003591.pub3. 
13. Merry, A. F. et al. Combined acetaminophen and ibuprofen for pain relief after oral surgery in adults: 
a randomized controlled trial. BJA Br. J. Anaesth. 104, 80–88 (2010). 
14. Miranda, H., Puig, M., Prieto, J. & Pinardi, G. Synergism between paracetamol and nonsteroidal anti-
inflammatory drugs in experimental acute pain. Pain 121, 22–28 (2006). 
15. Promoting Medication Adherence in Children - American Family Physician. 
https://www.aafp.org/afp/2006/0901/p793.html. 
16. Brian Haynes, R., Ann McKibbon, K. & Kanani, R. Systematic review of randomised trials of 
interventions to assist patients to follow prescriptions for medications. The Lancet 348, 383–386 
(1996). 
17. Uitti, J. M., Salanterä, S., Laine, M. K., Tähtinen, P. A. & Ruohola, A. Adaptation of pain scales for 
parent observation: are pain scales and symptoms useful in detecting pain of young children with the 
suspicion of acute otitis media? BMC Pediatr. 18, (2018). 
 
 
 


 
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APPROVAL DATE: 02/10/21 
RELEASED DATE: 02/10/21 
EXPIRATION DATE: 02/09/22 
 
 
INFORMED CONSENT DOCUMENT 
 
Project Title: 
Effectiveness of a Combined Acetaminophen and Ibuprofen Regimen for 
Management of Post-Tonsillectomy Pain in Pediatric Patients 
 
Principal Investigator: 
David Leonard 
 
Research Team Contact: 
Dr. David Leonard 314-454-2136 
 
 If you are the parent/guardian of a child under the age of 18 who is being invited to participate in this 
study, the word “you” in this document refers to your child.  As the parent/guardian, you will be 
asked to read and sign this document to give permission for your child to participate.   
 If you are under the age of 18 and reading this document, the word “you” in this document refers to 
you.  You will be asked to read and sign this document to indicate your willingness to participate. 
 
This consent form describes the research study and helps you decide if you want to participate.  It 
provides important information about what you will be asked to do during the study, about the risks and 
benefits of the study, and about your rights and responsibilities as a research participant. By signing this 
form you are agreeing to participate in this study. 
 You should read and understand the information in this document including the procedures, 
risks and potential benefits.  
 If you have questions about anything in this form, you should ask the research team for more 
information before you agree to participate.   
 You may also wish to talk to your family or friends about your participation in this study. 
 Do not agree to participate in this study unless the research team has answered your 
questions and you decide that you want to be part of this study.  
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study.  We invite you to participate in this research study because you are scheduled to 
undergo a tonsillectomy with or without adenoidectomy at St. Louis Children’s Hospital (SCLH) and 
the Children’s Specialty Care Center (CSCC). 
 
The purpose of this research study is to compare the effectiveness of a combined regimen of 
acetaminophen and ibuprofen dosed every 6 hours with the current practice of alternating 
acetaminophen and ibuprofen every 3 hours in the treatment of post-operative tonsillectomy pain. 
 
Acetaminophen and ibuprofen are approved by the U.S. Food and Drug Administration to reduce pain 
and fever. 
 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
You will be randomized (like flipping a coin) to either: 
 the alternating medication regimen which is the current practice of alternating doses of 


 
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RELEASED DATE: 02/10/21 
EXPIRATION DATE: 02/09/22 
 
 
Page 2 of 10 
acetaminophen and ibuprofen every 3 hours following surgery through the end of post-operative 
day 3 (POD 3); or  
 the combined medication regimen which is a combined dose of acetaminophen and ibuprofen 
every 6 hours following surgery through the end of POD 3  
 
Surgery will occur per standard protocol.  The surgery itself is not part of the research, however 
information about the surgery, including medications given during surgery, will be recorded for research 
purposes. As standard of care, all patients will receive a single dose of intravenous (IV) acetaminophen 
during surgery.  
 
The alternating treatment group will receive the first dose of oral ibuprofen 3 hours after the intra-
operative IV acetaminophen. All subsequent doses of alternating oral acetaminophen and ibuprofen will 
be given on an alternating basis, every 3 hours. Dosages are done as standard of care. 
 
The combined medication group will receive the first dose of oral ibuprofen in the post-anesthesia care 
unit (PACU) with all subsequent doses given as a combination of oral acetaminophen and ibuprofen 
every 6 hours. Dosages are done as standard of care. 
 
All patients are prescribed a rescue pain medication for breakthrough pain relief as needed. 
Breakthrough pain is severe pain that occurs while a patient is already medicated with a long-acting 
painkiller.  
 
Post operative pain scores will be measured when first awakening, at 30 minutes, and then hourly after 
PACU arrival, as well as at the time of discharge and prior to administration of rescue medication 
(medicine intended to relieve your symptoms immediately) if rescue medication is needed.  
 
Follow up surveys to assess pain scores will be completed twice a day on post-op days 1, 3, and 7.  
 
In the event you don’t have an email address or access to a smartphone or computer, you will be sent 
home with a copy of the surveys and the study team will call you to obtain your responses. 
 
You will record the timing of acetaminophen and ibuprofen, and the use of any breakthrough pain  
medication in a paper journal provided to you. Upon completion of the study medication regimen, at the 
end of POD 3, you may continue to provide pain relieving medications as needed using whichever 
regimen you prefer. You will continue to record medication usage and timing and pain scores through 
POD 7.  
 
We will collect information about you and your medical history as it relates to the surgery from your 
medical record for up to 30 days This information will be used for research. 
 
Will you save my research information to use in future research studies? 
 
We would like to use the data we are obtaining in this study for studies going on right now as well as 
studies that are conducted in the future.  These studies may provide additional information that will be 
helpful in understanding post-tonsilectomy pain management in pediatric patients or other diseases or 
conditions, including research to develop investigational tests, treatments, drugs or devices that are not 


 
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RELEASED DATE: 02/10/21 
EXPIRATION DATE: 02/09/22 
 
 
Page 3 of 10 
yet approved by the U.S. Food and Drug Administration.  It is unlikely that what we learn from these 
studies will have a direct benefit to you.  There are no plans to provide financial compensation to you 
should this occur.  By allowing us to use your data you give up any property rights you may have in the 
data. 
 
We will share your data with other researchers. They may be doing research in areas similar to this 
research or in other unrelated areas.  These researchers may be at Washington University, at other 
research centers and institutions, or industry sponsors of research.  We may also share your research data 
with large data repositories (a repository is a database of information) for broad sharing with the 
research community.  If your individual research data is placed in one of these repositories only 
qualified researchers, who have received prior approval from individuals that monitor the use of the 
data, will be able to look at your information.   
 
If you change your mind and do not want us to store and use your data for future research you should 
contact the research team member identified at the top of this document.  The data will no longer be 
used for research purposes. However, if some research with your data has already been completed, the 
information from that research may still be used. Also, if the data has been shared with other researchers 
it might not be possible to withdraw the data to the extent it has been shared. 
 
Please place your initials in the blank next to Yes or No for each of the questions below: 
 
My data may be stored and used for future research as described above. 
 
_____ Yes 
_____ No 
Initials  
Initials 
 
My data may be shared with other researchers and used by these researchers for the future 
research as described above. 
 
_____ Yes  
_____ No 
Initials  
Initials 
 
Identifiers may be removed from your private information and used for future research or shared with 
others. If this occurs, we will not ask you for additional consent.  
 
HOW MANY PEOPLE WILL PARTICIPATE? 
 
Approximately 100 people will take part in this study conducted by investigators at Washington 
University.   
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your involvement will last for approximately 8 days. We will be 
collecting data from their medical record for up to 30 days following your surgery. 
 


 
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RELEASED DATE: 02/10/21 
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Page 4 of 10 
 
 
WHAT ARE THE RISKS OF THIS STUDY? 
You may experience one or more of the risks indicated below from being in this study. In addition to 
these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this 
study.  
 
Ibuprofen  
Allergy alert - May cause severe allergic reaction, especially in people allergic to aspirin.  Symptoms 
may include: 
 Hives 
 Facial swelling 
 Asthma (wheezing) 
 Shock 
 Skin reddening 
 Rash 
 Blisters 
 
If an allergic reaction occurs, stop use and seek medical help right away. 
 
Stomach bleeding warning – ibuprofen contains NSAID, which may cause severe stomach bleeding.  
The chance is higher if you: 
 Have had stomach ulcers or bleeding problems 
 Take a blood thinning or steroid drug 
 Take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, 
naproxen or others) 
 Take more or for a longer time than directed 
 
Heart attack and stroke warning – NSAIDs, except aspirin, increase the risk of heart attack, heart failure, 
and stroke.  These can be fatal.  The risk is higher if you use more than directed or for longer than 
directed. 
 
Acetaminophen 
Liver warning - Severe liver damage may occur if you use more than directed. In case of overdose, get 
medical help or contact a Poison Control Center right away (1-800-222-1222). 
 
Breach of Confidentiality 
One risk of participating in this study is that confidential information about you may be accidentally 
disclosed.  We will use our best efforts to keep the information about you secure.  Please see the section 
in this consent form titled “How will you keep my information confidential?” for more information. 
 
WHAT ARE THE BENEFITS OF THIS STUDY? 
 
You may or may not benefit from being in this study.   
 


 
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Page 5 of 10 
However, we hope that, in the future, other people might benefit from this study because it will allow us 
to assess safety and effectiveness of combined pain medication versus the current practice of alternating 
each medication regimen following tonsillectomy. 
 
WHAT OTHER TREATMENT OPTIONS ARE THERE? 
 
Before you decide whether or not to be in this study, your doctor will discuss the other options that are 
available to you.  Instead of being in this study, you could receive the same medications without being in 
the research study. 
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
You and/or your medical/hospital insurance provider will remain responsible for your regular medical 
care expenses including the pain relieving medications.   
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will not be paid for being in this research study.   
 
WHO IS FUNDING THIS STUDY? 
 
The University and the research team are not receiving payment from other agencies, organizations, or 
companies to conduct this research study.  
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
Washington University investigators and staff will try to reduce, control, and treat any complications 
from this research. If you feel you are injured because of the study, please contact the investigator Dr. 
Leonard at 314-454-2136 and/or the Human Research Protection Office at 1-(800)-438-0445.  
 
Decisions about whether payment for medical treatment for injuries relating to your participation in 
research will be made by Washington University. If you need to seek medical care for a research-related 
injury, please notify the investigator as soon as possible.  
 
HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL? 
 
Other people such as those indicated below may become aware of your participation in this study and 
may inspect and copy records pertaining to this research.  Some of these records could contain 
information that personally identifies you. We will keep your participation in this research study 
confidential to the extent permitted by law.   
 Government representatives (including the Office for Human Research Protections) to complete 
federal or state responsibilities 
 The U.S. Food and Drug Administration 
 Hospital or University representatives to complete Hospital or University responsibilities 
 Information about your participation in this study may be documented in your health care records 
and will be available to anyone with access to your health care record, including your health 


 
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Page 6 of 10 
insurance company.  This information may also be released as part of a release of information 
request. 
 The last four digits of your social security number may be used in hospital or University systems 
to track billing information for research procedures. 
 Washington University’s Institutional Review Board (a committee that oversees the conduct of 
research involving human participants) and the Human Research Protection Office. The 
Institutional Review Board has reviewed and approved this study.  
 Any report or article that we write will not include information that can directly identify you.  
The journals that publish these reports or articles require that we share your information that was 
collected for this study with others to make sure the results of this study are correct and help 
develop new ideas for research. Your information will be shared in a way that cannot directly 
identify you. 
 
To help protect your confidentiality, we will assign you a study ID. The master list linking you and your 
study ID will be kept separate from your research record. Any report or article that we write will not 
include information that can directly identify you. The journals that publish these reports or articles 
require that we share your information that was collected for this study with others. Sharing this 
information will allow others to make sure the results of this study are correct and help develop new 
ideas for research. Your information will be shared in a way that cannot directly identify you. 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.  
 
Are there additional protections for my health information? 
 
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal 
law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this 
research, you must give the research team permission to use and disclose (share) your PHI for the study 
as explained in this consent form.  The research team will follow state and federal laws and may share 
your health information with the agencies and people listed under the previous section titled, “How will 
you keep my information confidential?” 
 
Once your health information is shared with someone outside of the research team, it may no longer be 
protected by HIPAA.   
 
The research team will only use and share your information as talked about in this form or as permitted or 
required by law.  When possible, the research team will make sure information cannot be linked to you 
(de-identified).  Once information is de-identified, it may be used and shared for other purposes not 
discussed in this consent form. If you have questions or concerns about your privacy and the use of your 
PHI, please contact the University’s Privacy Officer at 866-747-4975.  
 
Although you will not be allowed to see the study information, you may be given access to your health 
care records by contacting your health care provider.  
 
 


 
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Page 7 of 10 
If you decide not to sign this form, it will not affect 
 your treatment or the care given by your health provider. 
 your insurance payment or enrollment in any health plans.   
 any benefits to which you are entitled. 
However, it will not be possible for you to take part in the study. 
 
If you sign this form: 
 You authorize the use of your PHI for this research 
 This authorization does not expire. 
 You may later change your mind and not let the research team use or share your information 
(you may revoke your authorization).  
 To revoke your authorization, complete the withdrawal letter, found in the Participant section 
of the Human Research Protection Office website at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the 
investigator send you a copy of the letter.    
 
 
 
o If you revoke your authorization: 
 The research team may only use and share information already collected for 
the study. 
 Your information may still be used and shared as necessary to maintain the 
integrity of the research, for example, to account for a participant’s 
withdrawal from the research study or for safety reasons. 
 You will not be allowed to continue to participate in the study. 
 
Can we contact you by email? 
We would like to contact you by email for the purposes listed below.  Some of these emails may contain 
health information that identifies you. 
 Survey completion; appointment scheduling containing PHI 
 
Only the research team will have access to your email communications.  We will only communicate by 
email to send you the information listed above.  If you have any questions or need to contact us for an 
urgent or emergent situation, please contact the research team member identified at the top of this 
document. 
 
You should be aware that there are risks associated with sending your health information via email.   
 There is always a risk that the message could be intercepted or sent to the wrong email 
address.  To avoid sending messages to the wrong email address, the first email we send you 
will be a test message to ensure we have the correct email address. 
 When using any computer you should be careful to protect your username and password.  
Make sure you log-out before getting up from the computer.   
 If you share a home computer with other family members, and do not want them to know you 
are participating in this study make sure you provide an email address that only you can 
access.  
 Your employer will have access to any email communications sent or received on any 
electronic devices used for work or through a work server. 
  


 
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RELEASED DATE: 02/10/21 
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Page 8 of 10 
Do you agree to allow us to send your health information via email?   
 
_____ Yes  
_____ No 
Initials  
Initials 
 
IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If 
you decide to be in this study, you may stop participating at any time. Any data that was collected as 
part of your participation in the study will remain as part of the study records and cannot be removed.   
 
If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or 
lose any benefits for which you otherwise qualify.   
 
What if I decide to withdraw from the study? 
 
You may withdraw by telling the study team you are no longer interested in participating in the study or 
you may send in a withdrawal letter. A sample withdrawal letter can be found at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research 
Study. 
 
Will I receive new information about the study while participating? 
 
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information. 
 
Can someone else end my participation in this study? 
 
Under certain circumstances, the investigator might decide to end your participation in this research 
study earlier than planned.  This might happen for no reason or because in our judgment it would not 
be safe for you to continue. 
 
WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Dr. Leonard at 314-454-2136. If you experience a research-related injury, please contact: Dr. 
Leonard at 314-454-2136. 
 
If you have questions, concerns, or complaints about your rights as a research participant, please contact 
the Human Research Protection Office 1-(800)-438-0445, or email hrpo@wustl.edu.   General 
information about being a research participant can be found on the Human Research Protection Office 
web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to 
speak to someone other than the research staff, call the Human Research Protection Office at the number 
above. 
 
 


 
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APPROVAL DATE: 02/10/21 
RELEASED DATE: 02/10/21 
EXPIRATION DATE: 02/09/22 
 
 
Page 9 of 10 
This consent form is not a contract. It is a written explanation of what will happen during the study if 
you decide to participate. You are not waiving any legal rights by agreeing to participate in this study. 
As a participant you have rights and responsibilities as described in this document and including: 
 To be given enough time before signing below to weigh the risks and potential benefits and 
decide if you want to participate without any pressure from the research team or others. 
 To understand all of the information included in the document, have your questions answered, 
and receive an explanation of anything you do not understand. 
 To follow the procedures described in this document and the instructions of the research team to 
the best of your ability unless you choose to stop your participation in the research study. 
 To give the research team accurate and complete information. 
 To tell the research team promptly about any problems you have related to your participation, or 
if you are unable to continue and wish to stop participating in the research study. 
 
Your signature indicates that this research study has been explained to you, that your questions have 
been answered, and that you agree to take part in this study.  You will receive a signed and dated copy 
of this form. 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 02/09/22. 
 
__________________________________________ 
_______________________________ 
(Signature of Participant) 
 
 
 
 
(Date) 
 
____________________________________________ 
(Participant's name – printed) 
 
 
Parent/Guardian Name and Relationship to Participant: 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 02/09/22. 
 
 
_______________________________ 
(Child’s name – printed) 
 
 
__________________________________________ 
_______________________________ 
(Signature of Parent/Guardian) 
 
 
 
(Date) 
 
 
__________________________________________ 
_______________________________ 
(Name of Parent/Guardian- printed)  
 
 
(Relationship to participant – printed) 
 
 


 
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RELEASED DATE: 02/10/21 
EXPIRATION DATE: 02/09/22 
 
 
Page 10 of 10 
 
 
 
Statement of Person Who Obtained Consent 
 
The information in this document has been discussed with the participant or, where appropriate, with the 
participant’s legally authorized representative.  The participant has indicated that they understand the 
risks, benefits, and procedures involved with participation in this research study. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date) 
 
 
___________________________________________ 
(Name of Person who Obtained Consent - printed)