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Needle-Free sedation for Kids' broken bones? trial pulled before it started

NCT ID NCT03466242

Symptom relief Sponsor: Phoenix Children's Hospital 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 early-phase trial aimed to see if a nose spray sedative (dexmedetomidine) could safely and effectively sedate children aged 2–18 with a broken forearm, compared to the standard IV ketamine. The study was withdrawn before any participants were enrolled, so no data was collected. The goal was to offer a less invasive sedation option for fracture repair in the emergency department.

What this could mean

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

Active substance
Dexmedetomidine (intranasal)
What this could lead to
If it works, this could offer a needle-free sedation option for children with broken arms, reducing pain and anxiety during fracture repair.
What could go wrong
This trial was withdrawn before enrolling any participants, so no results are available. It is very early-stage, and the approach may not prove effective or safe compared to standard care.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Expected to start

Jan 2017

An estimate. Start dates often move.

Expected to finish

Mar 2020

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

2 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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:Verbal children aged 2-18 with a single extremity displaced forearm fracture requiring conscious sedation and reduction will be screened for enrollment. Exclusion Criteria: 1. Under age 2 years old or patients \> 18 years old 2. Multiple Fractures 3. Significant multisystem trauma 4. Glasgow Coma Scale (GCS \< 15) 5. Complex fractures that aren't deemed reducible in ED 6. Reported Allergy to Alpha -2-agonists 7. Pregnancy 8. Intoxication 9. Baseline Hypotension as \< 70mm Hg + 2 x age or \< 90mm Hg for patients \> 11 years of age 10. Patients with prior reductions attempted at outside facilities 11. Aberrant nasal anatomy that precludes IN medications 12. Chronic Health issues that can affect DEX metabolism 13. History of adverse reactions to anesthesia 14. Patients transferred from outside facilities 15. Open fractures

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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.

Conscious sedation Distal radius fracture

Contacts and locations

Locations

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

More trials for these conditions

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