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Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Supracondylar Humerus Fracture Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05640674
Study type Interventional
Source Baylor College of Medicine
Contact
Status Enrolling by invitation
Phase Phase 4
Start date September 12, 2023
Completion date June 2025
View Details
See also
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Completed NCT04582123 - Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins N/A
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Completed NCT01808183 - Pediatric Supracondylar Humerus Fracture NIRS Study
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Recruiting NCT04122781 - Treatment of Pediatric Supracondylar Humeral Fractures With Novel Kirschner Wire Fixation Devices N/A
Enrolling by invitation NCT06187584 - SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management Phase 4