Post-operative Pain Management in Children With Supracondylar Humerus Fractures

A Randomized Controlled Trial of Opioid vs Non-Opioid Postoperative Pain Management in Children With Supracondylar Humerus Fractures

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.

Study Overview

• Status: Terminated
• Conditions: Supracondylar Humerus Fracture
• Intervention / Treatment: Drug: Ibuprofen; Drug: Hydrocodone/acetaminophen; Drug: Acetaminophen

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 Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital - Main Campus
    • Houston, Texas, United States, 77094
      • Texas Children's Hospital - West Campus
    • Houston, Texas, United States, 77384
      • Texas Children's Hospital - Woodlands Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid Pain Management; 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.	Drug: Ibuprofen; Non-opioid; Other Names: Motrin, Advil; Drug: Hydrocodone/acetaminophen; Opioid; Other Names: Hycet
Experimental: Non-Opioid Pain Management; 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.	Drug: Ibuprofen; Non-opioid; Other Names: Motrin, Advil; Drug: Acetaminophen; Non-opioid; Other Names: Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Pain Scores on the FACES Scale	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).	from discharge until pain medication is no longer required (assessed up to 3 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Investigators: Principal Investigator: Scott Rosenfeld, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: November 29, 2022
• First Posted (Actual): December 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Organic Chemicals; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acids, Carbocyclic; Phenylpropionates; Acetaminophen; Ibuprofen; oxycodone-acetaminophen
• Other Study ID Numbers: 52475

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes