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Study identifier: NCT06489327 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Preoperative Anxiety  ·  Sponsor: Al-Azhar University

PhaseNA
Planned participants120
Who can joinAll sexes, 4 Years to 10 Years
Healthy volunteersNo

About this study

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 t…

This description comes directly from the study's public registry record.

Talk to the study team

Neveen Kohaf, Ph.D  ·  01060383012  ·  nevenabdo@azhar.edu.eg

Always discuss trial participation with your own doctor first.

Locations (2)

Facualty of Pharmacy, Al Azhar UniversityCairo, Cairo Governorate, EgyptRecruiting
Al-Ayen UniverisityMadīnat Bābil, Babel, IraqRecruiting

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Source record: clinicaltrials.gov/study/NCT06489327