Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 4 to 12

Pain control options after elbow surgery in children

Official title: A Randomized Controlled Trial of Acetaminophen and Ibuprofen Versus Acetaminophen and Oxycodone for Postoperative Pain Control in Operative Pediatric Supracondylar Humerus Fracture

Run by University of California, Los Angeles · NCT03759028 · Data updated 2026-11-12

This study is testing two different ways to manage pain after elbow surgery in kids to see which one works better and uses fewer strong medications.

Quick facts

PhasePhase 4
Study typeInterventional
Ages4 Years to 12 Years
SexAll
Enrollment90 (estimated)
SponsorUniversity of California, Los Angeles
Academic / other
Locations1 site (Los Angeles, California)
StatusRecruiting
StartedFebruary 26, 2019
Main results expectedDecember 1, 2027
Study endsDecember 20, 2027
Registry record updatedApril 7, 2026
Trial IDNCT03759028 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 5-12 with closed Gartland type II or III supracondylar humerus fractures requiring surgical fixation.

Probably not a fit

Patients with open fractures, those requiring open reduction, or those with significant concomitant injuries will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of two pain management strategies for pediatric patients undergoing surgery for closed supracondylar humerus fractures. Participants will be randomly assigned to receive either a combination of acetaminophen and ibuprofen or acetaminophen and oxycodone for post-operative pain relief. The study will assess pain levels using the Wong-Baker FACES scale and gather feedback from parents regarding their satisfaction with pain control. The goal is to determine which pain management approach is more effective while minimizing the use of narcotics.

Why it matters

Potential benefit: If successful, this study could provide safer and more effective pain management options for children recovering from elbow surgery.

How similar studies have gone: Other studies have shown promising results in using non-narcotic pain management strategies in pediatric populations, suggesting this approach may be effective.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Closed supracondylar humerus fracture
* Isolated supracondylar humerus fracture
* Type II and III supracondylar humerus fracture
* Fractures treated with closed reduction percutaneous pinning

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

Where it's running

  • Orthopaedic Institute for Children
    Los Angeles, California, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.