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Study tests if safer painkillers can replace opioids for Kids' broken elbows

NCT ID NCT06187584

Symptom relief Sponsor: Children's Mercy Hospital Kansas City 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 whether nonopioid pain relievers (acetaminophen and ibuprofen) work as well as opioids (hydrocodone/acetaminophen) for children after surgery for a severe elbow fracture. 137 children aged 4 to 10 were randomly assigned to one of the two pain regimens. Their pain levels were tracked for five days after surgery, and parents rated their satisfaction with pain control. The goal is to find a safer, effective standard for managing pain after this common childhood injury.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydrocodone/acetaminophen, acetaminophen, ibuprofen
What this could lead to
If successful, this could show that nonopioid pain relievers work just as well as opioids for children after this type of elbow surgery, reducing the need for stronger, riskier medications.
What could go wrong
This is a single completed study with 137 children, so results may not apply to all patients or fracture types. Pain is subjective, and individual responses vary.

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

137 people

The number who actually took part.

Started

Apr 2019

Finished

Dec 2023

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

5 to 9 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: * Patients presenting to Children's Mercy Hospital * Patients 48-119 months of age * Closed and completely displaced Gartland type III SCHFs (ICD-10 codes: S42.411A, S42.412A and S42.413A) Exclusion Criteria: * Patients younger than 48 months of age or older than 120 months of age * Nondisplaced SCHFs (ICD-10): S42.414-, S42.415- and S42.416-) * Open and completely displaced Gartland type III SCHFs (ICD-10: S42.411B, S42.412B and S42.413B) * Injury requiring open reduction and/or vascular injury requiring treatment * Patients presenting with additional injuries * Patients with known allergy to medications used in this study * Patients receiving regular treatment with opioids or NSAIDs * Patients with underlying medical issues affecting cognitive status * Patients with hepatic, gastrointestinal, renal or hematologic disease/disorders * Children that are wards of the state, prisoners or of CM employees * Non-English speaking families * Patients not admitted before and after surgery * Fractures not surgically treated within 18 hours of injury * Use of local anesthetic at surgical site

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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

  • Children's Mercy Hospital & Clinics

    Kansas City, Missouri, 64108, United States

More trials for these conditions

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