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Can Over-the-Counter meds replace opioids for Kids' elbow pain?

NCT ID NCT05640674

Symptom relief Sponsor: Baylor College of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at two common ways to manage pain in children after elbow fracture surgery: opioids versus over-the-counter medications like ibuprofen and acetaminophen. The goal was to see if non-opioid options work just as well, reducing the need for opioid prescriptions. The study was terminated early with only 29 participants enrolled.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

29 people

The number who actually took part.

Started

Sep 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

humerus fracture

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Supracondylar humerus fracture

Contacts and locations

Locations

  • Texas Children's Hospital - Main Campus

    Houston, Texas, 77030, United States

  • Texas Children's Hospital - West Campus

    Houston, Texas, 77094, United States

  • Texas Children's Hospital - Woodlands Campus

    Houston, Texas, 77384, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.