Post-operative Pain Management in Children With Supracondylar Humerus Fractures

Phase 4

• Conditions: Supracondylar Humerus Fracture
• Interventions: Drug: Ibuprofen; Drug: Hydrocodone/acetaminophen; Drug: Acetaminophen

• Registration Number: NCT05640674
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Status Verified: 2023-09
• Study Start: 2023-09-12
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-12
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid Pain Management	Hydrocodone/acetaminophen	Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management	Acetaminophen	Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Opioid Pain Management	Ibuprofen	Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Hydrocodone/Acetaminophen (liquid, 0.135mg Hydrocodone/kg/dose every 6 hours) will be used as needed for breakthrough pain.
Non-Opioid Pain Management	Ibuprofen	Ibuprofen (liquid, 10mg/kg/dose every 6 hours) will be the first line pain medication and Acetaminophen (liquid, 15mg/kg/dose every 6 hours) will be used as needed for breakthrough pain.

Primary Outcome Measures

Name	Time	Method
Daily Pain Scores on the FACES Scale	from discharge until pain medication is no longer required (assessed up to 3 weeks)	A parent/guardian will ask participants to rate their pain severity using the Wong-Baker FACES scale, which ranges from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Name	Time	Method
Number of Pain Medication Doses Required per Day	from discharge until pain medication is no longer required (assessed up to 3 weeks)	A parent/guardian will record the doses of pain medications given to the participant each day.
Number of Days Pain Medication Required	from discharge until pain medication is no longer required (assessed up to 3 weeks)	A parent/guardian will record the doses of pain medications given to the participant each day.

Trial Locations

Locations (3)

Texas Children's Hospital - West Campus; 🇺🇸 Houston, Texas, United States

Texas Children's Hospital - Woodlands Campus; 🇺🇸 Houston, Texas, United States

Texas Children's Hospital - Main Campus; 🇺🇸 Houston, Texas, United States