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Can melatonin or a nebulized drug calm kids after surgery?

NCT ID NCT07345715

Symptom relief Sponsor: Tanta 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving children oral melatonin or a nebulized drug called dexmedetomidine before surgery can reduce confusion and agitation when they wake up after adenotonsillectomy. About 96 children aged 3 to 7 will be randomly assigned to one of three groups: melatonin, dexmedetomidine, or a placebo. The goal is to find a safer, gentler way to help kids recover calmly.

What this could mean

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

Active substance
oral melatonin syrup or nebulized dexmedetomidine
What this could lead to
If it works, this could point toward a simple, safe way to calm children after surgery without strong sedatives.
What could go wrong
This is a small, early-phase trial with only 96 children, so results may not apply to all kids or surgeries. Neither drug is guaranteed to work better than placebo.

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 96 people

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

Started

Jul 2025

Expected to finish

Jul 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

3 to 7 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: * Children aged between 3 and 7 years. * Both sexes. * Classified as American Society of Anesthesiologists (ASA) physical status I or II according to the American Society of Anesthesiologists. * Scheduled for elective adenotonsillectomy under general anesthesia. Exclusion Criteria: * Parental refusal to participate in the study. * Known allergy or hypersensitivity to dexmedetomidine, melatonin or midazolam. * Presence of developmental delay. * Central nervous system disorders. * Intellectual disability (formerly termed mental retardation). * Neurological or psychiatric conditions associated with anxiety or agitation (e.g., cerebral palsy, epilepsy, separation anxiety disorder, attention-deficit/hyperactivity disorder). * Current or recent treatment with anticonvulsants or sedative medications

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Conditions

The condition(s) this trial relates to.

Emergence Delirium

As listed by the trial registrant

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

Adenotonsillectomy Children Emergence agitation Nebulized dexmedetomidine Oral melatonin

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

  • Tanta University

    RECRUITING

    Tanta, El-Gharbia, 31527, Egypt

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