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New nasal spray may help kids stay calmer after surgery

NCT ID NCT06417125

Symptom relief Sponsor: Fujian Provincial 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tested whether a nasal spray medicine (dexmedetomidine) given before surgery could reduce negative behavior changes in children after surgery, compared to a standard oral medicine (midazolam). 324 children aged 2-5 years having tonsil surgery took part. Researchers tracked behavior changes for up to 30 days after surgery.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

324 people

The number who actually took part.

Started

May 2024

Finished

Oct 2025

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 5 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. ASA physical status I or II; 2. Aged 2-5 years; 3. Scheduled for elective tonsillectomy and (or) adenoidectomy. Exclusion Criteria: 1. Parents refusing to allow their children to participate; 2. Intake of sedative or analgesic medication within 48 hours before surgery; 3. Developmental delay; 4. Psychosis; 5. Body mass index \> 30 kg/m2; 6. Allergy to study drugs; 7. Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.; 8. Any other conditions that precluded study inclusion.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium psychiatric disorder

As listed by the trial registrant

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

Behavior problem

Contacts and locations

Locations

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001, China

More trials for these conditions

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