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NCT05640674
Post-operative Pain Management in Children With Supracondylar Humerus Fractures
Conditions: Supracondylar Humerus Fracture
Sex: All
Ages: 3 Years – 12 Years
Phase: PHASE4
Enrollment: 100
Sponsor: Baylor College of Medicine
Location: United States
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.
Eligibility 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 HospitalPatients/guardians must speak English or SpanishExclusion Criteria:Fractures associated with open skin wounds, polytrauma, neurologic deficit, or vascular deficitPatients 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.
Source: ClinicalTrials.gov (NCT05640674). StuddyBuddy aggregates publicly available trial information.