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

NCT06489327 — Not applicable, Recruiting, 120 participants, Al-Azhar University

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

Registry	NCT06489327
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, prevention
Enrollment	120 (Estimated)
Sponsor	Al-Azhar University (Other); collaborators: Al-Ayen Iraqi University
Conditions	Preoperative Anxiety
Interventions	melatonin (Circadin ®) 0.2 mg/kg, melatonin (Circadin ®) 0.4 mg/kg, placebo group (Drug)
Dates	start 2026-07-12 (estimated), primary completion 2026-12-15 (estimated), completion 2026-12-15 (estimated), first posted 2024-07-05, last updated 2026-01-06
Locations	2 sites in Egypt, Iraq

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
1st group: melatonin 0.2 mg/kg group	Active comparator	Drug: melatonin (Circadin ®) 0.2 mg/kg	patients will receive oral melatonin at a dose of 0.2 mg/kg
2nd group: M04 groupmelatonin 0.4 mg/kg group	Active comparator	Drug: melatonin (Circadin ®) 0.4 mg/kg	patients will receive oral melatonin at a dose of 0.4 mg/kg
3rd group: placebo group	Placebo comparator	Drug: placebo group	patients will receive oral placebo premedication

melatonin (Circadin ®) 0.2 mg/kg (Drug): 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 (Drug): 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 (Drug): 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.

+Outcome measures

Primary outcomes

preoperative anxiety [24 hours]: The child's anxiety level will be assessed by Visual analogue scale-anxiety (VAS-A). The VAS-A consists of a 100 mm horizontal line; the left edge of the line is marked as "calm," while the other end shows "maximum anxiety." The patients were asked to assess their own anxiety and mark it on the anxiety line.

Secondary outcomes

preoperative sedation [24 hours]: The sedation level will be assessed using Ramsay Sedation Scale. It divides a patient's level of sedation into six categories ranging from severe agitation at 1 to deep coma at 6.

+Eligibility

Sex: All, ages: 4 Years to 10 Years

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.

+Locations (2)

Facility	City	Country	Status
Facualty of Pharmacy, Al Azhar University	Cairo, Cairo Governorate	Egypt	Recruiting
Al-Ayen Univerisity	Madīnat Bābil, Babel	Iraq	Recruiting

+Investigators

Neveen Kohaf, ph.d, Principal investigator, Al-Azhar University