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Melatonin may soothe agitation in kids after tonsil surgery

NCT ID NCT07375342

Symptom relief Sponsor: Benha University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This study tests whether giving children melatonin before tonsillectomy surgery can reduce confusion and agitation when they wake up. About 120 children will receive either melatonin or a placebo 30 minutes before anesthesia. Researchers will measure agitation levels and recovery time.

What this could mean

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

Active substance
melatonin
What this could lead to
If it works, this could offer a simple, low-cost way to help children wake up more calmly after tonsillectomy.
What could go wrong
This is a small, early-stage trial. Melatonin may not reduce agitation better than placebo, and some children may have side effects like drowsiness.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

Dec 2025

Expected to finish

Aug 2026

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

4 to 10 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 or II. * Parent/legal guardian provides written informed consent Exclusion Criteria: * • Known allergy or contraindication to melatonin. * Pre-existing neurological or psychiatric disorders (e.g., epilepsy, autism, ADHD). * Children receiving any sedative or psychoactive medication within 48 hours of surgery. * Emergency surgery or any procedure other than tonsillectomy/adenoidectomy. * Children with known sleep disorders or those taking melatonin supplements. * Developmental delay, neurologic disorders, sleep disorders, or known obstructive sleep apnea requiring ICU postoperatively. * Hepatic or renal dysfunction (ALT/AST \>2×ULN, Cr \>1.5 mg/dL)

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Conditions

The condition(s) this trial relates to.

Psychomotor Agitation

As listed by the trial registrant

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

Post tonsillectomy emergence agitation

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

  • Benha University Hospital

    RECRUITING

    Banhā, Egypt