Post-operative Pain Management in Children With Supracondylar Humerus Fractures

NCT05640674 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 52475
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Supracondylar Humerus Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Days Pain Medication Required

  from discharge until pain medication is no longer required (assessed up to 3 weeks)

• Number of Pain Medication Doses Required Per Day

  from discharge until pain medication is no longer required (assessed up to 3 weeks)

Study Arms (2)

Opioid Pain Management

ACTIVE COMPARATOR

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; Drug: Hydrocodone/acetaminophen

Non-Opioid Pain Management

EXPERIMENTAL

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; Drug: Acetaminophen

Interventions

Ibuprofen DRUG

Non-opioid

Also known as: Motrin, Advil

Non-Opioid Pain Management; Opioid Pain Management

Hydrocodone/acetaminophen DRUG

Opioid

Also known as: Hycet

Opioid Pain Management

Acetaminophen DRUG

Non-opioid

Also known as: Tylenol

Non-Opioid Pain Management

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (3)

Texas Children's Hospital - Main Campus

Houston, Texas, 77030, United States

Location

Texas Children's Hospital - West Campus

Houston, Texas, 77094, United States

Location

Texas Children's Hospital - Woodlands Campus

Houston, Texas, 77384, United States

Location

MeSH Terms

Interventions

Ibuprofen; oxycodone-acetaminophen; Acetaminophen

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Limitations and Caveats

The study was terminated early due to insufficient enrollment, resulting in inadequate data to meaningfully assess the primary outcome.

Results Point of Contact

• Title: SCOTT ROSENFELD, MD
• Organization: Baylor College of Medicine/ Texas Children's Hospital

sbrosenf@texaschildrenshospital.org

832-824-1000

Study Officials

• Scott Rosenfeld, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: December 7, 2022
• Study Start: September 12, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)