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Can extra painkillers help kids with broken bones?

NCT ID NCT02477007

Symptom relief Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 304 children aged 2 to 17 with broken arm or leg bones who came to the emergency room in severe pain. Researchers wanted to see if giving paracetamol (Tylenol) or ibuprofen (Advil) along with morphine worked better than morphine alone. They measured pain levels 30 minutes after treatment to find the best way to ease children's pain quickly.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

304 people

The number who actually took part.

Started

Dec 2015

Finished

Nov 2018

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

2 to 17 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: * children aged 2 through 17 years (17 years included) * suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department) * within the first 12 hours after the injury * at least one signed parental informed consent * affiliated to health insurance Exclusion Criteria: * analgesic treatment within the 6 hours before inclusion * contraindication to one of the experimental drug: Paracetamol or Ibuprofen * contraindication to Morphine * cognitive impairment * multiple injuries * resuscitation manœuvres * suspected femur fracture * open fracture * pregnant women in the third trimester

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Conditions

The condition(s) this trial relates to.

bone fracture Pain

As listed by the trial registrant

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

Long bone fractures Pain

Contacts and locations

Locations

  • Paediatric emergency Armand Trousseau hospital

    Paris, 75012, France

More trials for these conditions

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