A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
Phase: PHASE4
Conditions: Supracondylar Humerus Fracture
Sponsor: University of California, Los Angeles

A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and 
Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus 
Fracture 
 
NCT03759028 
 
Unique Protocol ID# 18-001158 
Date of Document: 11/14/2018 

Research Design and Methods: Describe in detail the design and methodology of the study. 
This is a double-blinded, randomized controlled trial comparing the analgesic efficacy between 
acetaminophen and ibuprofen versus acetaminophen and oxycodone for postoperative pain control in 
patients following closed reduction and percutaneous pinning for isolated closed supracondylar 
humerus fractures. Each patient will be evaluated initially at our institution’s pediatric urgent care 
center and placed in a long arm splint with instructions to elevate the affected arm. Patients will not be 
discharged with any prescriptions for narcotic pain medication and will be instructed to take weight- 
based doses of acetaminophen and/or ibuprofen for pain control as needed. All patients age 5-12 with 
closed Gartland type II supracondylar humerus fractures requiring fixation (e.g. satisfactory reduction 
not achieved with closed reduction and casting or medial column comminution) and Gartland type III 
supracondylar humerus fractures scheduled for surgery will be approached for participation in the 
study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at home, 
insurance type) will be obtained through chart review on each included patient. The exclusion criteria 
include open fractures, fractures with concomitant vascular or neurologic deficit, any fracture requiring 
open reduction, pathologic fractures, those presenting with concomitant injuries, swelling requiring 
post-operative hospitalization for monitoring, any known history of allergies to acetaminophen, 
ibuprofen or oxycodone, and patients with developmental delay that would preclude participation in the 
visual analog Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to 
participate in the study, and assent will be obtained from patients when possible. If parents refuse 
participation in the study, the reason for refusal will be documented, and their child’s care and post- 
operative protocol will be consistent with our typical protocol, which includes all 3 medications. All 
surgeries will be performed at our outpatient surgery center. The treating pediatric anesthesiologists  
will use a standardized anesthesia protocol. All patients will be under general anesthesia and will not 
receive any regional anesthetics or local anesthetics. All included patients will undergo closed reduction 
and percutaneous pinning using 2-3 pins placed either all laterally or medially and laterally by two 
pediatric orthopaedic surgeons (MS and RT). They will al be placed in posterior long arm splints 
thereafter and made non-weight bearing in that extremity. The patients will be transferred to our post- 
anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed for before 
discharge home. Nursing staff will record the amount of pain medication provided in the PACU as well as 
the pre-discharge pain scores, as is our typical post-operative protocol. Prior to discharge, patients will 
be randomized to receiving acetaminophen for first-line medication (liquid oral medication, 
15mg/kg/dose every 6 hours as needed, max 90mg/kg/day) with as needed ibuprofen for breakthrough 
pain (liquid oral medication, 10mg/kg/dose every 8 hours as needed, max dose 40mg/kg/day) or 
acetaminophen for first-line medication (liquid oral medication, 15mg/kg/dose every 6 hours as needed, 
max 90mg/kg/day) with as needed oxycodone for breakthrough pain (liquid oral medication, 
0.1mg/kg/dose every 6 hours as needed). Each patient will receive 18 doses (3 days) of acetaminophen 
and the study medication. Pre-sealed, sequentially numbered randomization envelopes containing each 
subject’s group will be delivered to the hospital pharmacy. Patients will be instructed to first take the 
labeled acetaminophen medication and to take the study medication (unlabeled) as needed for 
breakthrough pain as prescribed. Patients will be given both patient information for both study 
medications in order to keep the patients blinded to which study medication they received. They will be 
given patient information for both medications but told that they have been given only one of the two 
medications. Medication labels will be obscured by the pharmacist with a circumferential tape. 
Throughout the study, the investigators and the parents will be blinded as to which study medication 

was given to each participant. Parents who contact the physician (a resident physician on-call for the 
pediatric orthopaedic surgery service who is not involved in the study) post-operatively for alternative 
pain medication will be provided the study medication not initially provided (i.e. those that were 
randomized to receive oxycodone primarily will be provided ibuprofen and vice versa), as confirmed by 
our pharmacy. Post-operatively, the parents of each participant will be asked to use the Faces Pain 
Scale-Revised (FPS-R)16 to rate the child’s level of pain at 24 hours and 48 hours after surgery. A 
research team member will call each participant’s guardian at 24 and 48 hours postoperatively to collect 
these responses. Parents will further be asked to complete the modified Total Quality Pain Management 
Instrument (TQPM)17 regarding their level of satisfaction with surgery and post-operative pain control. 
Parents will be asked to report any side effects (e.g. nausea, vomiting, lethargy, constipation) associated 
with the medications. A take-home medication log will be utilized by the parents to record the type and 
amount of mediation given to each participant and to record any associated side effects. For 
breakthrough pain experienced during pharmacy hours the patient will have the option to return to our 
pharmacy to obtain the medication they were not originally prescribed. Though we believe this will be 
unlikely, if they are unable to get to the pharmacy for the other medication (e.g. oxycodone if they were 
in the ibuprofen group or ibuprofen if they were in the oxycodone group), parents can go to the ER for 
IM/IV medication for pain relief and they can get a prescription for oxycodone or ibuprofen from the ER 
if necessary, once they contact the resident on call. There will always be a resident on call 24/7 to advise 
patients if they are unable to achieve adequate pain control with medications received. Again, we 
believe this will be an unlikely/rare event. The resident on call will have access to the study medication 
that the patient received. At this point, the resident on call can reveal what medication they were 
getting (in case they need a new prescription from the ER) so they do not get oxycodone if they were 
already prescribed oxycodone (and can get something different) or they have the option to obtain 
ibuprofen over-the-counter if they wish. Patients who need to get the other medication would be 
considered a "failure in treatment" and would not be analyzed together from the original group. 
 
 
 
Statistics and Data Analysis: Describe the proposed statistical procedures or descriptive analyses for 
the study. If applicable, indicate how the sample size was determined. 
Sample size was based on the self-reported pain scale (FPS-R, FACES Pain Scale-Revised) which is a 0 to 
10 scale. A standard deviation of approximately 1.6 was assumed. With a sample size of 45 patients in 
each group, given a power of 80% and an alpha of 0.05, the study will be able to detect differences of 1 
or larger (on the scale 0 to 10). Based on this previous study, this is a sufficiently large sample to detect 
clinically significant differences. 
Baseline characteristics of the study groups will be summarized using descriptive statistics. Spearman 
rank correlation will be used to determine whether numerical data points were non-parametric. For 
non-parametric continuous variables, Mann-Whitney-U test will be used. Student’s T-tests will be 
utilized to analyze parametric variables. For categorical variables, comparisons will be completed using 
the Fischer’s Exact Test for non-parametric data and Chi-Squared Test for parametric data. 
Patients who fail the treatment drug (e.g. requires another medication in addition to the medications 
initially prescribed) will not be included in the original group for analysis. They will be accounted for with 

Kaplan-Meier analysis comparing the number of failures in each group (which will also account for the 
time at which they required the "rescue" medication).