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Nose spray pain relief for kids: which works best?

NCT ID NCT05057689

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study planned to compare three different medications given as nose sprays to children aged 2 to 6 years who needed stitches for a cut. The goal was to see which one worked best for pain and anxiety during the procedure. However, the trial was withdrawn before any children were enrolled, so no results are available.

What this could mean

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

Active substance
Intranasal dexmedetomidine, intranasal fentanyl, intranasal midazolam
What this could lead to
If it had succeeded, this could have pointed toward a better way to manage pain and anxiety in young children during minor emergency procedures.
What could go wrong
The trial was withdrawn before enrolling any participants, so no results are available. It was also a small Phase 2 study, meaning even if completed, findings would need further confirmation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Oct 2025

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 6 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: * Primary complaint of "laceration" * 2 years to 6 years of age (inclusive) * Initial presentation at the Arkansas Children's Hospital (ACH) Emergency Department Exclusion Criteria: * Prior allergic reaction to fentanyl or midazolam or dexmedetomidine * Prior major adverse reaction to fentanyl or midazolam (e.g. seizure-like activity, paradoxical reaction, hallucinations) * Nasal injury/deformity * Potential for altered pain perception (e.g. autism, severe sensory-neural disturbances) * History of adverse reaction to sedation/anesthesia * History of cardiac arrhythmia * History of liver dysfunction * Concurrent injuries that would necessitate higher levels of care (e.g. inpatient admission, immediate evaluation in the operating room (OR), etc.) * Complex (multi-layer) lacerations or those requiring subspecialty consultation for repair * American Society of Anesthesiology (ASA) score ≥ 3 * Use of analgesics (with the exception of ibuprofen or acetaminophen) or anxiolytics in the immediate pre-examination period (within 4 hours)

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Conditions

The condition(s) this trial relates to.

acute stress disorder anxiety anxiety disorder Pain Stress Disorders, Traumatic, Acute

As listed by the trial registrant

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

Contacts and locations

Locations

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202, United States

More trials for these conditions

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