What this study is
The purpose of this study to investigate post-operative pain control in pediatric patients with closed supracondylar humerus fracture who undergo closed reduction and percutaneous pinning. Currently, it is standard of care that patients receive a narcotic prescription for post-operative pain control. All patients will initially be seen in our pediatric urgent care and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the acetaminophen but both investigators, parents and the patients will be blinded to the study drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This study is being conducted in hopes of reducing opioid prescription after surgical fixation of uncomplicated supracondylar humerus fractures if our study can show that patient's pain levels post-operatively and parent/patient satisfaction are unchanged or improved in the acetaminophen and ibuprofen arm.
What's being tested
- Ibuprofen
Intervention · DRUG
- Oxycodone
Intervention · DRUG
- Acetaminophen
Intervention · DRUG
All interventions
Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
Study details
- Official title
- A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
- Sponsor
- University of California, Los Angeles
- Conditions
- Supracondylar Humerus Fracture
- Enrolling
- 90 people
- Starts
- 2019-02-26
- Est. completion
- 2027-12-20
- Design
- Double-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 4 Years – 12 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Closed supracondylar humerus fracture
- Isolated supracondylar humerus fracture
- Type II and III supracondylar humerus fracture
- Fractures treated with closed reduction percutaneous pinning
You can't join if
- Fractures with concomitant vascular injury
- Fractures with concomitant neurologic deficit
- Pathologic fractures
- Fractures with concomitant injuries (multiple trauma)
- Fractures with swelling requiring post-operative hospitalization for monitoring
- Known history of allergies to acetaminophen, ibuprofen or oxycodone
- Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised
- Patients with intellectual disability that would preclude participation in the visual analog Faces Pain Scale-Revised
- History of suspected child abuse
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOrthopaedic Institute for Children
Los Angeles, California, United States
- Jared Alswang · Contact2137426537JAlswang@mednet.ucla.edu
- Christina K Sun · Contact2137421057CKSun@mednet.ucla.edu
Recruiting
Study team
Sponsor
University of California, Los Angeles
Study ID IRB# 18-001158
Principal investigator
Mauricio Silva, MD
UCLA/OIC
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.