Supracondylar Post-Operative Pain Study (NCT03759028)
A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (10 items).
Location: Orthopaedic Institute for Children — Los Angeles, California
Age range: 4 Years to 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Orthopaedic Institute for Children — Los Angeles, California
📞 Contact the Study Coordinator
Phone: (213) 742-1074
Email: LLHan@mednet.ucla.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Each patient will receive 18 doses (3 days) of acetaminophen and the study medication.
Explore by condition: All Supracondylar Humerus Fracture clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.