TerminatedPhase 4

Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Stopped: After reviewing our enrollment numbers and feasibility, we have decided to close the study due to low enrollment.

United States29 participantsStarted 2023-09-12

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Closed, Gartland type III supracondylar humerus fracture * Fractures treated with closed reduction and percutaneous pinning (CRPP) * Patients expected to follow up at Texas Children's Hospital * Patients/guardians must speak English or Spanish Exclusion Criteria: * Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficit * Patients who have impaired ability to report pain severity such as intellectual delay. * Patients who have a problem with bone healing such as osteogenesis imperfecta. * Patients who are unable to take the standard dose of acetaminophen, ibuprofen, or hydrocodone (allergy, severe kidney disease, etc). * Patients who are on chronic NSAID or opioid medication prior to injury. * Patients with injury from suspected non-accidental trauma.

What they're measuring

Daily Pain Scores on the FACES Scale

Timeframe: from discharge until pain medication is no longer required (assessed up to 3 weeks)

Trial details

NCT IDNCT05640674

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-15

Results submitted2025-12-15