RecruitingNot ApplicableNCT06489327

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

Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial


Sponsor

Al-Azhar University

Enrollment

120 participants

Start Date

Jul 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different doses of oral melatonin given before surgery in children, to see which dose is better at reducing anxiety and helping with sedation before anesthesia. Melatonin is a natural sleep hormone that may help children feel calmer before an operation. **You may be eligible if...** - Your child is between 4 and 14 years old - Your child is scheduled for a routine (elective) surgery - Your child is in generally good health (ASA I or II status) **You may NOT be eligible if...** - Your child has a serious underlying health condition (ASA III or higher) - Your child has a known drug allergy - Your child has a gastrointestinal disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGmelatonin (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.

DRUGmelatonin (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.

DRUGplacebo 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06489327


Related Trials