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Could a single injection stop post-surgery delirium in children?

NCT ID NCT07704437

Symptom relief Sponsor: University Hospital of Split 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial investigates whether a drug called remimazolam can prevent emergence delirium—a state of confusion and agitation—in children aged 3 to 12 after tonsillectomy or similar procedures. Children are randomly assigned to receive either remimazolam or a placebo (salt water) before anesthesia. The study measures delirium, pain, recovery time, and parent satisfaction.

What this could mean

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

Active substance
remimazolam, a sedative drug given by injection
What this could lead to
If effective, remimazolam could become a standard way to prevent emergence delirium in children after surgery, making recovery calmer and safer.
What could go wrong
This is an early-phase trial with a small number of children, so results may not apply broadly. Remimazolam may cause side effects like drowsiness or allergic reactions.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

110 people

The number who actually took part.

Started

Apr 2024

Finished

May 2026

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

3 to 12 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: * American Society of Anesthesiologists (ASA) physical status I * Children undergoing scheduled tonsillectomy/adenoidectomy or combined procedure Exclusion Criteria: * American Society of Anesthesiologists (ASA) physical status \> 1 * Known hypersensitivity to remimazolam or other benzodiazepines

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Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium

As listed by the trial registrant

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

Emergence delirium Remimazolam Tonsillectomy

Contacts and locations

Locations

  • UH Split

    Split, Split-Dalmatia County, 21000, Croatia

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