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New study seeks to reduce sedation for children with broken wrists

NCT ID NCT07120763

Symptom relief Sponsor: State University of New York at Buffalo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two lighter pain control methods for children aged 3 to 17 who need a wrist fracture reduction. One method uses a numbing injection (hematoma block) with a low dose of ketamine, and the other uses the same block with fentanyl nasal spray. These are compared to the standard full sedation with ketamine. The goal is to see if these alternatives control pain just as well while avoiding deep sedation.

What this could mean

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

Active substance
Ketamine, Lidocaine, Fentanyl
What this could lead to
If successful, this could provide safer, less sedating pain control options for children with wrist fractures, reducing the need for full sedation.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply to all children. The alternative methods may not control pain as well as full sedation.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

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 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 requiring reduction for distal radius fracture * Children presenting to the emergency department * Children who are ages 3 to 17 years. Exclusion Criteria: * Pediatric patients \<3 years old * Adult patients (i.e. ages 18 or up) * Pediatric patients with injury patterns that are not amenable to hematoma block. * Children who are not a candidate for sedation related to BMI \> 95%tile for age, ASA class \> 2, Mallampati score \> 2, and pregnant patients

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Conditions

The condition(s) this trial relates to.

agnosia bone fracture radius fracture

As listed by the trial registrant

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

Distal radius fracture reduction Pain control Pediatric fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Oshei Children's Hospital

    RECRUITING

    Buffalo, New York, 14203, United States

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