Clinical trial NCT04905563
Conditions: Supracondylar Humerus Fracture
Keywords: Elbow surgery Pain
Sponsor: Le Bonheur Children's Hospital
Start date: 2021-06-07; Completion date: 2024-01-05
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.

Detailed description:
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.

Arms: arm 1: Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose arm 2: Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Interventions: intervention 1: Acetaminophen-Hydrocodone intervention 2: Acetaminophen and Ibuprofen
Intervention descriptions: intervention 1: Narcotic intervention 2: Non-narcotic

Protocol documents:
ICF_001.pdf: 
Main Consent Form
08/07/2023
Page 1 of 11
                
Parent/Legal Guardian Initials _____
                           
TITLE: 
Post-operative pain management in Supracondylar Humerus Fractures: A 
randomized, double-blinded, prospective study.
PRINCIPAL INVESTIGATOR:
Lindsey N. Locke, MSN, CPNP-PC
Le Bonheur Children’s Hospital
848 Adams Ave.
Memphis, TN 38103
CO-INVESTIGATOR(S):
Derek M. Kelly, MD
Benjamin W. Sheffer, MD
Jeffrey R. Sawyer, MD
William C. Warner, MD
Leslie N. Rhodes, DNP, PPCNP-BC
1.  KEY INFORMATION:
A person who takes part in a research study is called a research or study subject.  In this consent 
form “you” refers to the research subject and/or the parent/legal guardian. You are being given 
the opportunity to participate in this research study.  The purpose of this consent form is to help 
you decide if you want to be in the research study.  
The purpose of this study is to determine if using the combination of acetaminophen (also known 
as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain 
control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with 
broken elbows who need surgery. The acetaminophen, ibuprofen, and acetaminophen-
hydrocodone are in liquid form and will be given orally.
We want to know if using the combination of acetaminophen and ibuprofen can provide pain 
control as well as or better than acetaminophen-hydrocodone so that doctors might be able to 
prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. 
Currently, the standard of care for pain control following this kind of elbow surgery is 
acetaminophen-hydrocodone.
Procedures:
In this study, we will randomize subjects between different treatments to compare their success 
and safety. 
You will be randomly assigned (like the flip of a coin) to receive acetaminophen and ibuprofen 
or acetaminophen-hydrocodone.  You have a 1 in 2 chance of receiving acetaminophen and 
ibuprofen, the experimental treatment.  The investigator will not be the person who decides 
which you receive.  A computer program that gives random numbers will be used to decide 
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 2 of 11
                
Parent/Legal Guardian Initials _____
                           
which you receive.  It is not known whether the experimental treatment is as good as, better than, 
or worse than the standard treatment.
Neither you, the principal investigator, nor any personnel giving you the study medicines will 
know which treatment you will receive or have received.  This is important for the research 
design so that neither you, the principal investigator, nor anyone giving you the study medicines, 
will know about the developing trends in the research information being gathered.  However, in 
case of an emergency, the principal investigator can find out which treatment you have received.
Your participation in this study will last approximately 4 days. This includes your time spent in 
the hospital and a one-time phone call 2-3 days after you are discharged.  
The following procedures are being performed for research purposes only:  

Being randomized to receive either acetaminophen and ibuprofen or acetaminophen-
hydrocodone

The collection of information from your medical record, such as pain scores, medications 
received, date and time of surgery, anesthesia records, total amount of intravenous (IV) 
medication received, complications

Receiving a telephone call to fill out a questionnaire after you are discharged from the 
hospital.
For a detailed explanation of the procedures, refer to the section of this consent form entitled, 
DETAILED PROCEDURES TO BE FOLLLOWED.
Risks:
The most common side effects of acetaminophen are dizziness and heartburn. The most common 
side effects of ibuprofen are dizziness and heartburn. The most common side effects of 
hydrocodone are nausea and vomiting.
For a detailed list of the potential risks, refer to the section of this consent form entitled, RISKS 
ASSOCIATED WITH PARTICIPATION.
Benefits:
If you are randomized to receive standard therapy, it is likely to be as safe and effective in 
treating your pain as it is when given outside the research setting.  If you are randomized to 
receive acetaminophen and ibuprofen, its safety and effectiveness in treating pain may be the 
same as, better than, or worse than standard treatment. The benefits of the study drugs are less 
certain because it is still being tested for the treatment of your condition.  
The results of this study may help children with broken elbows in the future by helping their pain 
after surgery without using medicines that can be addictive.
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 3 of 11
                
Parent/Legal Guardian Initials _____
                           
Alternatives:
You may receive acetaminophen and ibuprofen without participating in this study. 
If you decide not to enter this study, there are other choices available.  These include 
acetaminophen-hydrocodone and ibuprofen.  Ask the study staff to discuss these alternatives 
with you.  You do not need to be in this study to receive treatment for your condition.
You will receive medical treatment for pain following elbow surgery whether or not you 
participate in the study.  
Voluntary Participation:
Your participation in this research study is voluntary.  You may decide not to participate or you 
may leave the study at any time.  Your decision will not result in any penalty or loss of benefits 
to which you are entitled. 
Deciding to not take part in this research study will not change your regular medical care in any 
way.  
2. DETAILED PROCEDURES TO BE FOLLOWED:
150 subjects will be participating in this study.
The study will take place at Le Bonheur Children’s Hospital, 848 Adams Ave., Memphis, 
Tennessee 38103.
Prior to Surgery:

Information such as your age, weight, height, medical history, total amount of 
intravenous (IV) medication received, and pain scores will be copied from your medical 
record. You will be randomized to receive either the standard or experimental treatment. 
After Surgery:

Information such as pain scores, medications received, date and time of surgery, 
anesthesia records,  medications, total amount of intravenous (IV) medication received, 
complications, etc. will be copied from your medical record.

You will receive either acetaminophen and ibuprofen or acetaminophen-hydrocodone 
every 6 hours for pain, and either medicine you receive will be flavored with cherry 
syrup.

You will receive intravenous (IV) morphine for additional pain relief if needed.

If you receive the experimental medicine (acetaminophen and ibuprofen), and you need 2 
doses of additional pain relief in a row, you will be switched to standard of care pain 
medicine (acetaminophen-hydrocodone).
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 4 of 11
                
Parent/Legal Guardian Initials _____
                           

You will receive instructions for post-operative pain management at home and 
prescriptions for pain medication if needed.
After Discharge from Hospital:

Follow up information will be collected by telephone 48-72 hrs (2-3 days) after you are 
discharged from the hospital. This will include up to 10 questions about how your child 
felt after going home from the hospital and will take about 5 minutes.
Your participation in this research study may be stopped by the study staff without your consent 
for any of the following reasons:

If the study medications are not controlling your pain

If your diagnosis changes

If you do not follow the study staff’s instructions
If you decide to stop taking part in this research study, you should tell your study staff, and any 
information that you have already provided will be kept in a confidential manner
3. RISKS ASSOCIATED WITH PARTICIPATION:
All drugs can have side effects.  Although not all or none of these side effects may occur, if they 
do occur, they may need medical attention.  You must notify your study staff about all 
symptoms, side effects, complaints, illnesses, or injuries which you experience during the course 
of the study regardless of whether or not you think these are related to the study drug.  You 
should discuss these with your study staff as well as your regular health care provider, if you 
choose.
As a result of your participation in this study, you are at risk for the following side effects.
Acetaminophen may cause some, all, or none of the side effects listed below.
Occasional (6-20%) 

Dizziness

Heartburn
Rare (1-5%)

Itching

Constipation

Nausea

Vomiting
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 5 of 11
                
Parent/Legal Guardian Initials _____
                           

Agitation

Collapsed lung

Headache

Sleeplessness
Very Rare (less than 1%)

Heart attack

Heart failure

High blood pressure

Kidney failure

Liver failure
Ibuprofen may cause some, all, or none of the side effects listed below.
Occasional (6-20%) 

Dizziness

Heartburn
Rare (1-5%)

Itching

Constipation

Nausea

Vomiting

Agitation

Collapsed lung

Headache

Sleeplessness
Very Rare (less than 1%)

Heart attack

Heart failure

High blood pressure

Kidney failure

Liver failure
Hydrocodone may cause some, all, or none of the side effects listed below.
Occasional (6-20%) 

Nausea

Vomiting
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 6 of 11
                
Parent/Legal Guardian Initials _____
                           
Rare (1-5%)

Constipation

Dizziness

Headache

Sleeplessness

Tiredness

Ringing in the ears

Inability to sleep

Decreased appetite

Agitation

Collapsed lung
If you are not randomized to the experimental treatment, you will not be exposed to the risks 
(listed above) associated with the study drug, Ibuprofen while you are in the hospital.
There is a risk that your private identifiable information may be seen by people not involved in 
the research (such as if a researcher’s computer is stolen or an electronic database is hacked).  
However, we will use very careful security measures (such as locks on file cabinets, computer 
passwords, etc.) to minimize the chance that any unauthorized persons might see your 
confidential information.  
The research may involve risks to you which are currently unforeseeable.  You will be told about 
any new information that might change your decision to be in this study.  You may be asked to 
sign a new consent form if this occurs.
4. CONFIDENTIALITY:
Research records 
All your paper research records will be stored in locked file cabinets and will be accessible only 
to research personnel and those entities named below in this section, except as required by law 
(such as reports of child abuse, plans to commit suicide, etc.).
All your electronic research records will be computer password protected and accessible only to 
research personnel and those entities named below in this section, except as required by law 
(such as reports of child abuse, plans to commit suicide, etc.).  
Your private information collected as part of this research, even if identifiers are removed, will 
not be used or distributed for future research studies.
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 7 of 11
                
Parent/Legal Guardian Initials _____
                           
Medical Records
Information about your participation in this study or the results of procedures performed in this 
study will be placed in your medical record; as such, this information could be made available to 
your employer or insurer.
Presentations/Publications 
While individual details about your case might be provided in publications or presentations about 
this research, they will not be discussed in a way that would allow you to be individually 
identified as a participant.
Limits to Confidentiality
Information obtained during the course of the study, which in the opinion of the investigator(s) 
suggests that you may be at significant risk of harm to yourself or others, may be reported to a 
third party to protect the rights and welfare of those at potential risk.
Authorization to Use and Disclose Protected Health Information for Research Purposes 
Under federal privacy regulations, you have the right to decide who can review and copy your 
identifiable health information (called “protected health information” or PHI).  PHI collected in 
this study may include information such as:

Past and present medical records

Records about your study visits

Records about phone calls made as part of this research

Research records  
By signing this consent form, you are giving your permission for the study staff to get your PHI 
from your doctor and/or facilities where you have received health care.  They may also share 
your PHI with:

The Institutional Review Board (IRB) at the University of Tennessee Health Science Center

The US Food and Drug Administration (FDA)

Department of Health and Human Services (DHHS) or other government agencies

Le Bonheur Children’s Hospital

Your medical insurance provider

Campbell Foundation which sponsors and provides funds for this research

Campbell Clinic
Your PHI will only be used and/or given to others:

To do the research

To study the results

To see if the research was done correctly
Your PHI will be used until the study is completed.
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 8 of 11
                
Parent/Legal Guardian Initials _____
                           
You may withdraw or take away your permission to use and disclose your PHI at any time.  You 
do this by sending written notice to the principal investigator.  If you withdraw your permission, 
you may not be able to stay in the study.
When you withdraw your permission, no new PHI will be gathered after that date.  However, 
information that has already been gathered may still be used and given to others.  The federal 
regulations allow you to review or copy your PHI that is used in this study.  
However, in order to complete the research, your access to this PHI may be temporarily 
suspended while the research is in progress.  Once the study is over, your right to review and 
copy your PHI will be reinstated.
5. COMPENSATION AND TREATMENT FOR INJURY:
You are not waiving any legal rights or releasing the University of Tennessee, Le Bonheur 
Children’s Hospital, or the agents of either, from liability for negligence.  In the event of 
physical injury resulting from research procedures, the University of Tennessee and Le Bonheur 
Children’s Hospital do not have funds budgeted for compensation for medical treatment. 
Therefore, the University of Tennessee and Le Bonheur Children’s Hospital do not provide for 
treatment or reimbursement for such injuries.  
If you are injured or get sick as a result of being in this study, call the study doctor, Derek Kelly, 
MD, immediately.  The study doctor will provide acute medical treatment, and will provide you 
with a subsequent referral to appropriate health care facilities. 
If you are injured or get sick as a result of being in this study, you and/or your insurance will be 
billed for the costs associated with this medical treatment.
No compensation will be available to you for any extra expenses that you may have as the result 
of research-related physical injuries, such as additional hospital bills, lost wages, travel expenses, 
etc.
No compensation will be available to you for any non-physical injuries that you may have as a 
result of research participation, such as legal problems, problems with your finances or job, or 
damage to your reputation.
6. QUESTIONS:
Contact Jonathan Rowland, BS at 901-287-5413 if you have questions about your participation 
in this study, or if you have questions, concerns, or complaints about the research.    
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
08/07/2023
Page 9 of 11
                
Parent/Legal Guardian Initials _____
                           
If you feel you have had a research-related injury or a reaction to the study drug, contact Derek 
M. Kelly, MD, at 901-759-3100 (24-hour/7-day answering service). 
You may contact Cameron Barclay, MSA, UTHSC IRB Director, at 901-448-4824, or visit the 
IRB website at http://www.uthsc.edu/research/compliance/irb/ if you have any questions about 
your rights as a research subject, or if you have questions, concerns, or complaints about the 
research.
7. PAYMENT FOR PARTICIPATION:
You will not be paid for participation in this research study.  
8. COSTS OF PARTICIPATION:
There are no costs to you for participating in this study. The Campbell Foundation will provide 
the study drug free of charge during this study. Tests and procedures that are done only for 
research purposes will not be billed to you or your insurance company. 
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
05/05/2021
Page 10 of 11
9. CONSENT OF SUBJECT:
You have read or have had read to you a description of the research study as outlined above.  The 
investigator or his/her representative has explained the study to you and has answered all the 
questions you have at this time.  You knowingly and freely choose to participate in the study.  A 
copy of this consent form will be given to you for your records.
_____________________________________________
Printed Name of Minor Research Subject (Ages 4-13)
_____________________________________________
___________ __________
Signature of Parent/Legal Guardian
Date
             Time
____________________________________________
Printed Name of Parent/Legal Guardian 
Check Relationship to Minor:    

Parent

Court-Appointed Legal Guardian 
____________________________________________
___________ __________
Signature of Person Obtaining Consent
Date
Time
____________________________________________
Printed Name of Person Obtaining Consent
In my judgment, the parent/legal guardian has voluntarily and knowingly given informed consent 
and possesses the legal capacity to give informed consent to participate in this research study.
__________________________________________
___________ _________
Signature of Investigator
Date
Time
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024


Main Consent Form
05/05/2021
Page 11 of 11
Assent Discussion for Subjects 8-13 Years of Age
A. Assent Obtained:
 
The assent discussion was initiated on ______________ (date) at __________ (time).
The information was presented in age-appropriate terms. 
   
____________________________
_______________________      
Minor Subject’s Printed Name (8-13 years)
Minor Subject’s Date of Birth
________________________________                             
__________    
__________
Minor Subject’s Signature (8-13 years)          
Date                    Time
* Please note that the parent/legal guardian must sign the consent signature page above.
I hereby certify that I have discussed the research project with the minor subject and/or his/her 
parent/legal guardian.  I have explained all the information contained in the informed consent 
document, including any risks that may be reasonably expected to occur.  I further certify that the 
research subject was encouraged to ask questions and that all questions were answered.
__________________________________________
Printed Name of Person Obtaining Assent
__________________________________________
__________
__________
Signature of Person Obtaining Assent
Date
Time
B. Assent Not Obtained, but Minor Subject was Enrolled:
Assent of the minor subject was NOT obtained for the following reason:
 Minor is cognitively or emotionally unable to participate in an assent discussion (e.g., minor has 
either a psychiatric or developmental disorder; minor received narcotics within the last 4 hours; 
minor is sedated; etc.).
C. Assent Was Obtained, but Minor Subject was Unable to Sign:
 The minor assented to participation, but has an incapacity that prevents applying a signature (e.g., 
the subject’s dominant hand is incapacitated, the subject is illiterate, etc.).  The assenting subject’s 
inability to sign the assent document has been duly noted in the research record.
IRB NUMBER: 19-06536-FB
IRB APPROVAL DATE: 08/07/2023
IRB EXPIRATION DATE: 07/24/2024

Prot_SAP_002.pdf: 
Post-operative Pain Management in Supracondylar Humerus Fractures: 
A Randomized, Doubleblinded, Prospective Study  
NCT04905563 
Study Protocol and Statistical Plan 
05/05/2021 
 
 


Protocol 
1.  Purpose: The purpose of this study is to determine if scheduled nonsteroidal anti-inflammatory drugs 
(NSAIDs) provide equal or better pain control compared to scheduled opioids (standard of care) post-
operatively in pediatric patients with SCHFs undergoing CRPP.  
2. Background: Supracondylar humerus fractures (SCHFs) are the most common pediatric elbow fracture 
in children ages five to seven years old.  Treatment is dependent on the type of fracture, but often includes 
surgical intervention with a closed reduction and percutaneous pins.  
Pain following an orthopedic injury is most severe in the first forty-eight hours and is often undertreated 
in both children and adults (Clark, Plint, Correll, Gaboury, & Passi, 2016; Lim, 2015). Several studies 
have compared acetaminophen, ibuprofen and codeine for postoperative pain control in children; 
however, to our knowledge, there is limited research directly comparing scheduled acetaminophen and 
ibuprofen to scheduled acetaminophen-hydrocodone for postoperative pain control in children with 
supracondylar humerus fractures (SCHFs) undergoing a closed reduction percutaneous pinning (CRPP). 
A study conducted by Swanson, Chang, Schleyer, Pizzutillo and Herman (2012) compared 
acetaminophen to acetaminophen/codeine in children with type two and type three SCHFs and found 
decreased pain scores in the children treated with acetaminophen, although not statistically significant. 
Lim conducted a study in 2015 in which children were randomized into two groups following a fracture 
to an extremity. Group 1 received intravenous morphine for postoperative pain and Group 2 received 
ibuprofen for postoperative pain. Both groups received acetaminophen for breakthrough pain. Children in 
both groups had adequate pain control, but there was no statistical difference between the two. In a study 
by Morris, Stulberg, Stevemer and Kickner (2010), pediatric patients with simple fractures that did not 
require reduction or manipulation were given ibuprofen or acetaminophen with codeine. Pain control was 
equivalent between the groups; however, children preferred ibuprofen over acetaminophen-codeine, 
which allowed them to return to play faster and eating sooner. Additionally, researchers followed the 
patients’ charts for four years and found no increased risk of fracture or delay in healing in the ibuprofen 
group. Clark, Plint, Correll, Gaboury and Passi found that ibuprofen significantly decreased pain at 60, 90 
and 120 minutes following an acute orthopedic injury compared to acetaminophen or codeine (2016).  
3. Inclusion Criteria: Children ages 4-13 years old with an isolated supracondylar humerus fracture 
(SCHF), extension and flexion type, undergoing closed reduction with percutaneous pinning (CRPP). 
Exclusion Criteria: Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone. Liver 
or renal disease, history of bleeding disorder, medical diagnosis of juvenile arthritis, on chronic NSAIDs 
or Opioids PRIOR to the procedure, medical diagnosis of coagulopathies, open fractures, other injuries at 
time of diagnosis (multi-system trauma), vascular compromise and/or compartment syndrome upon 
admission, any patient/family who does not speak English. 
4. Design: Randomized, double blinded, prospective study during the time period of 4/01/2019 to 
12/31/2024 
5.  Protocol: Informed consent will be obtained prior to treatment. Informed consent will occur in the 
clinic, the emergency department, or the preoperative department, and will not delay the treatment of the 
subjects. Subjects will be randomly assigned to one of two groups: Group A (treatment) receives 
scheduled acetaminophen and ibuprofen and Group B (control) receives scheduled acetaminophen-
hydrocodone (standard of care).  Prior to surgery, pain for all participants will be controlled with IV 
Morphine 0.1 mg/kg/dose every two hours as needed. Post-operatively, patients in the NSAID group will 
receive acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 
650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen. Patients in the opioid group will receive 


acetaminophen-hydrocodone 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose. All 
medications will be drawn up by a pharmacist in opaque bottles to look the same, be the same volume, be 
the same color. All medications will be flavored with cherry syrup. A master list of subjects and the 
medications given will be kept in a password protected spreadsheet in the pharmacy. The total volume of 
all medications will be determined by the pharmacist and dependent on the patient’s weight with a max 
volume of 40 milliliters (Figure 1). Post-operatively, all participants in this study will receive IV 
Morphine for breakthrough pain (standard of care) in addition to the scheduled medications they were 
randomly assigned to. Pain scores (standard of care) will be documented in the patient’s electronic 
medical record (EMR) by the bedside nurse every two hours, prior to administration of pain medication 
and thirty minutes after administration of pain medication using the Wong-Baker Faces Pain Scale. 
Patients can receive IV Morphine for breakthrough pain after sixty minutes of receiving oral pain 
medications if their pain is not adequately controlled. All patients who experience emesis within thirty 
minutes of receiving oral pain medications will be given an additional dose of their oral medications (per 
standard of care). Upon discharge, patients will be given a prescription for acetaminophen-hydrocodone 
0.15 mg/kg/dose and ibuprofen 10 mg/kg/dose, which is standard of care at LeBonheur. Follow up 
email/text will be done 48-72 hrs post- discharge from hospital via Twilio.  
Perioperative steroids for this procedure are not used by the surgeons involved.  
Surgery scheduling for these patients varies due to patient NPO status, OR availability, surgeon 
availability, and time of presentation.  
If a patient received ibuprofen prior to presentation, they still may be randomized to either treatment 
group. 
Acetaminophen and ibuprofen will be administered simultaneously, not in separate syringes. 
Patients receiving the experimental treatment needing 2 consecutive doses of break through medicines for 
pain control will be switched to standard of care medicine. All nurses who staff the orthopedic floor will 
be trained by the PI (who is the nurse practitioner for the orthopedic service) on this and all procedures 
listed in the study protocol.   
 
Figure 1 
Weight Based Volumes 
Weight 
Volume 
10-14.9 kg 15 mL 
15-19.9 kg 20 mL 
20-24.9 kg 25 mL 
25-29.9 kg 30 mL 
30-34.9 kg 35 mL 
35+ kg 
40 mL 
6. Outcome Measures: Pain, amount of narcotics used, amount of NSAID used, total morphine 
equivalents, cost, length of stay, side effects of medications. 


References 
World Health Organization (WHO)- Analgesia Ladder 2018 
National Institute on Drug Abuse. Opioid Overdose Crisis. http://www.drugabuse.gov 
Swanson, Chang, Schleyer, Pizzutillo, & Herman. (2012). Postoperative pain control after 
supracondylar humerus fracture fixation. Journal of Pediatric Orthopaedics, 32(5). 
Lim (2015). Postfracture pain relief in children can be adequately managed with ibuprofen. BMJ, 
20(3). 
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Statistical Analysis Plan (SAP):  
We intend to examine the difference in pain scores between two groups of children for postoperative 
orthopedic pain using a two sided Mann-Whitney-Wilcoxon test. Additionally, we plan to use mixed 
linear regression model to consider between-group differences in pain score across all the time points. We 
will also compare medication usage, cost, length of stay, and side effects between the two groups. 
In addition to testing each variable individually, we plan to use multivariate analysis techniques like 
multivariate analysis of variance (MANOVA) or multivariate regression can be used to simultaneously 
assess the effects of multiple variables while controlling for overall type I error. 
The plan is to conduct two-sided Mann-Whitney-Wilcoxon test and the critical assumptions necessary to 
be verified were (1) Ensuring the comparability of the variable under examination across the two groups, 
necessitating it to be continuous, (2) Affirming the non-normal or skewed distribution of the data, (3) 
Confirming the independence of the samples, which were selected randomly, (4) Ensuring similarity in 
the distribution shapes of the data across both groups, notwithstanding the assumption that neither group's 
data adhered to a normal distribution.