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Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
Sponsor: Al-Azhar University
Summary
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.
Official title: Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
Key Details
Gender
All
Age Range
4 Years - 10 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-07-12
Completion Date
2026-12-15
Last Updated
2026-01-06
Healthy Volunteers
No
Conditions
Interventions
melatonin (Circadin ®) 0.2 mg/kg
Patients will receive oral melatonin at a dose of 0.2 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
melatonin (Circadin ®) 0.4 mg/kg
Patients will receive oral melatonin at a dose of 0.4 mg/kg as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
placebo group
Patients will receive oral placebo as premedication in the morning of the surgery, 90 minutes before the induction of anesthesia, with a maximum dose of melatonin set at 10 mg.
Locations (2)
Facualty of Pharmacy, Al Azhar University
Cairo, Cairo Governorate, Egypt
Al-Ayen Univerisity
Madīnat Bābil, Babel, Iraq