Nose spray pain relief for kids: which works best?
NCT ID NCT05057689
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 However, the trial was withdrawn before any children were enrolled, so no results are available.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- The trial was withdrawn before enrolling any participants, so no results are available.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 Hide 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.
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
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