Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a sleep hormone stop Children's Post-Surgery delirium?

NCT ID NCT05541276

Prevention Sponsor: Arash Afshari Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time

Summary

This trial tests whether giving melatonin intravenously during surgery can prevent the agitation and delirium some children experience when waking up from anesthesia. About 1 in 4 children show these distressing behaviors, which include crying, thrashing, and confusion. The study will compare melatonin against a placebo in 676 children aged 1 to 6 undergoing elective surgery, measuring how many develop emergence agitation and their need for pain medication afterward.

What this could mean

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

Active substance
Melatonin given as an intravenous injection during surgery
What this could lead to
If effective, a single dose of IV melatonin during surgery could become a simple, safe way to prevent distressing post-anesthesia agitation in young children.
What could go wrong
This is a phase 3 trial, but results may not confirm benefit. Melatonin has low bioavailability, and the trial's success depends on the dose and timing working in a real surgical setting.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 676 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Apr 2027

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

1 year to 6 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: * Patients aged 1-6 years * Elective surgical procedure of en axpected duration of at least 30 minutes in general anesthesia Exclusion Criteria: * Any known allergy or contraindication to study treatment or excipåients * Current daily medication with melatonin

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Emergence delirium are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

delirium Emergence Delirium Pain, Postoperative Postoperative Nausea and Vomiting

As listed by the trial registrant

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

Emergence delirium

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Anesthesiology, Juliane Marie Center, Rigshospitalet

    RECRUITING

    Copenhagen, Capital Region, 2100, Denmark

More trials for these conditions

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