Could melatonin be the key to calming anxious kids before surgery?
NCT ID NCT06489327
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether a dose of melatonin, a natural sleep hormone, can reduce anxiety in children before surgery. 120 kids aged 4 to 14 will receive either a low dose, a higher dose, or a placebo 90 minutes before anesthesia. The goal is to see if melatonin works as well as or better than standard sedatives, with fewer side effects.
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 safer alternative to midazolam for calming children before surgery, with fewer side effects.
- What could go wrong
- This is a small, early-phase trial with only 120 participants. Melatonin may not reduce anxiety better than a placebo, and the optimal dose is unknown.
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
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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
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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4 to 10 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 of either sex * age from 4 to 14 years * Patients with American society Anesthesiologist physical status I and II * Patients undergoing elective surgeries Exclusion Criteria: * ASA more than III * Drug allergy. * Gastrointestinal disorders.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Al-Ayen Univerisity
RECRUITINGMadīnat Bābil, Babel, 51015, Iraq
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Facualty of Pharmacy, Al Azhar University
RECRUITINGCairo, Cairo Governorate, 11765, Egypt
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