Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Preoperative Anxiety

In brief

Preoperative anxiety is a common issue in pediatric anesthesia. Children often experience anxiety and uneasiness due to uncertain outcomes. Surgery and anesthesia are among the most traumatic experiences for children, often considered anxiety-inducing medical treatments. Because they lack control over their environment and circumstances, children undergoing medical procedures typically experience significant unease or anxiety. Several studies have reported that 50%-80% of children experience preoperative anxiety. In order to reduce kids anxiety intensity, several measures are utilized. These strategies are either pharmacological, psychological, or behavioural. Benzodiazepines are popular drugs that can reduce anxiety in children. The most used one in premedication is midazolam. It is a rapid-acting benzodiazepine that has a short elimination half-life. It has sedative, anxiolytic, hypnotic, and anterograde amnesic effects. Midazolam, on the other hand, might have a number of negative consequences, including paradoxical reactions, interactions with opioids, excessive sedation, disorientation, and reduced psychomotor performance. Melatonin enhances anti-nociceptive effects, most prominently through the modulation of MT1/MT2 receptors in the brain and spinal cord. In addition, it has been demonstrated that melatonin can interact with additional receptors, including those in the GABAergic system, the nitric oxide (NO)arginine route, the N-Methyl-D-aspartate (NMDA) system, and the dopaminergic system, to produce anti-nociceptive and anti-allodynic effects.

Key facts

Study ID

NCT06489327

Run by

Al-Azhar University

People needed

120

Starts

2026-07-12

Expected to finish

2026-12-15

Last updated by the study team

2026-01-06

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of either sex
• age from 4 to 14 years
• Patients with American society Anesthesiologist physical status I and II
• Patients undergoing elective surgeries

You may not qualify if…

• ASA more than III
• Drug allergy.
• Gastrointestinal disorders.

Where it is running

• Facualty of Pharmacy, Al Azhar University — Cairo, Cairo Governorate, Egypt (enrolling)
• Al-Ayen Univerisity — Madīnat Bābil, Babel, Iraq (enrolling)

Full record on ClinicalTrials.gov

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