Clinical trial NCT05640674: Post-operative Pain Management in Children With Supracondylar Humerus Fractures
Official title: A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Supracondylar Humerus Fracture
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Daily Pain Scores on the FACES Scale
timeFrame: from discharge until pain medication is no longer required (assessed up to 3 weeks)
Secondary outcomes:
measure: Number of Pain Medication Doses Required per Day
timeFrame: from discharge until pain medication is no longer required (assessed up to 3 weeks)
measure: Number of Days Pain Medication Required
timeFrame: from discharge until pain medication is no longer required (assessed up to 3 weeks)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital - Main Campus
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital - West Campus
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital - Woodlands Campus
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Scott Rosenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References: