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Could a sedative boost pain relief for children with broken bones?

NCT ID NCT00416039

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether adding a sedative (midazolam) to standard morphine painkiller helps children with arm fractures feel less pain. Sixty children aged 5 to 16 were split into two groups: one got morphine plus midazolam, the other got morphine plus a placebo. Researchers measured pain levels at different times to see if the combination worked better.

What this could mean

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

Active substance
midazolam and morphine
What this could lead to
If it works, this could offer a better way to manage pain and anxiety in children with arm fractures in the emergency room.
What could go wrong
This is a small, single-center study with only 60 children, so results may not apply broadly. Adding midazolam also carries risks like drowsiness or breathing problems.

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

60 people

The number who actually took part.

Start date

Jan 2007

Finished

Feb 2009

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 16 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 between 5 and 16 years old * children with a disjoined bone fracture * children needed oral morphine analgesia * written informed consent from one or the two parents or legal pad Exclusion Criteria: * ASA score \> 2 * concomitant administration of oral analgesia (level II WHO classification) less than 6 hours * concomitant administration of benzodiazepine less than 24 hours

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Conditions

The condition(s) this trial relates to.

bone fracture

As listed by the trial registrant

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

Fractures

Contacts and locations

Locations

  • Hopital Necker enfants Malade - Department of Pediatric Emergency

    Paris, 75015, France

More trials for these conditions

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