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Could skipping sedation for Kids' wrist fractures be just as effective?

NCT ID NCT05131685

Disease control Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial looks at two approaches for treating displaced wrist fractures in children aged 4 to 10. One group gets the standard sedated reduction (where the bone is realigned under sedation) followed by a cast. The other group gets only a cast without any realignment. The study measures how well the arm functions afterward, aiming to see if the simpler, less invasive approach works just as well.

What this could mean

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

Active substance
closed reduction under conscious sedation
What this could lead to
If casting alone works as well as reduction, many children could avoid sedation and its risks, simplifying treatment.
What could go wrong
This is a mid-sized trial; results may not apply to all fracture types or ages. Casting alone might lead to slower healing or worse function in some cases.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 334 people

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

Started

Apr 2023

Expected to finish

Jul 2031

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

4 to 10 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: 1. Provision of signed and dated informed consent form by parent or legal guardian 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 4-10 years 4. Diagnosis of 100% dorsally displaced radius metaphyseal fracture with any or no ulna involvement 5. Fracture is less than 5cm from the distal radial growth plate 6. Willing to adhere to the immobilization regimen 7. Fracture is acute (occurred less than 10 days prior to consent and assignment of treatment arm AND with ability to be taken to operating room (OR) or reduced in the emergency department (ED) Exclusion Criteria: 1. Physeal involvement of fracture 2. Presence of open fracture, pathologic fracture, neuromuscular disease, or metabolic disease 3. Fractures other than the ulna near the same level in the ipsilateral arm 4. Fracture cannot be treated with acute reduction due to being older than 10 days 5. Patient and parents are unable to adhere to procedures or complete follow-up due to insufficient comprehension of consent form or surveys or developmental delay

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Conditions

The condition(s) this trial relates to.

radius fracture Wrist Fractures

As listed by the trial registrant

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

Fracture distal radius

How to take part

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

  1. The places running it

    24 sites. 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

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Cincinnati's Children's Hospital

    RECRUITING

    Cincinnati, Ohio, 452229, United States

  • Gillette Children's Specialty Healthcare

    RECRUITING

    Saint Paul, Minnesota, 55101, United States

  • Hospital of Special Surgery

    RECRUITING

    New York, New York, 10021, United States

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • Nemours Children's Hospital

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • Niklaus Children's Hospital

    RECRUITING

    Miami, Florida, 33155, United States

  • Oregon Health and Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Phoenix Children's Hospital

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • Riley Children's

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Riley Children's Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • TRIA Health Partners

    RECRUITING

    Minneapolis, Minnesota, 55102, United States

  • Texas Children's Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Texas Scottish Rite Hospital for Children

    RECRUITING

    Dallas, Texas, 75219, United States

  • University Hospital- Rutgers

    RECRUITING

    New Brunswick, New Jersey, 07103, United States

  • University Hospitals Rainbow Babies & Children

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California- Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico - Carrie Tingley

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of North Carolina at Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14642, United States

More trials for these conditions

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