Post-operative Pain Management in Children With Supracondylar Humerus Fractures

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Ibuprofen

Criteria

Inclusion Criteria:

• Closed supracondylar humerus fracture (Gartland type II or III)

• 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.