NCT05640674

Post-operative Pain Management in Children With Supracondylar Humerus Fractures

A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

There are two common and concurrently used strategies for pain management following surgical treatment of supracondylar humerus (elbow) fractures in children: opioids vs over the counter pain medications. The purpose of this study is to determine if ibuprofen and acetaminophen can provide similar or better pain relief compared to ibuprofen and hydrocodone/acetaminophen (also known as Hycet) for this population of children after they have been discharged. If over the counter medications can provide adequate pain relief, then fewer opioid prescriptions would be necessary. This reduces early opioid exposure and decreases unnecessary opioids in circulation.

Detailed description

Prior to surgery, participants will be randomly assigned to a group that will determine whether they are prescribed an opioid vs non-opioid pain management plan at discharge. Each participants' parent or guardian will be given a journal to keep track of their child's pain severity and the pain medications taken. The journal will updated daily until participants no longer require pain medication. Participants will follow up with their surgeon per usual at their post-operative visits.

Conditions

• Supracondylar Humerus Fracture

Interventions

Type	Name	Description
DRUG	Ibuprofen	Non-opioid
DRUG	Hydrocodone/acetaminophen	Opioid
DRUG	Acetaminophen	Non-opioid

Timeline

• Start date: 2023-09-12
• Primary completion: 2025-12-15
• Completion: 2025-12-15
• First posted: 2022-12-07
• Last updated: 2026-02-10
• Results posted: 2026-02-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study