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

NCT06489327 | Recruiting

• 1 other identifier: 042/2021/Babel
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Preoperative Anxiety

Keywords

preoperative anxiety; general anesthesia; major surgery; oral melatonin; placebo; premedication

Outcome Measures

Primary Outcomes (1)

• preoperative anxiety

  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.

  24 hours

Secondary Outcomes (1)

• preoperative sedation

  24 hours

Study Arms (3)

1st group: melatonin 0.2 mg/kg group

ACTIVE COMPARATOR

patients will receive oral melatonin at a dose of 0.2 mg/kg

Drug: melatonin (Circadin ®) 0.2 mg/kg

2nd group: M04 groupmelatonin 0.4 mg/kg group

ACTIVE COMPARATOR

patients will receive oral melatonin at a dose of 0.4 mg/kg

Drug: melatonin (Circadin ®) 0.4 mg/kg

3rd group: placebo group

PLACEBO COMPARATOR

patients will receive oral placebo premedication

Drug: placebo group

Interventions

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.

1st group: melatonin 0.2 mg/kg group

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.

2nd group: M04 groupmelatonin 0.4 mg/kg group

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.

3rd group: placebo group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Al-Azhar University: lead
• Al-Ayen Iraqi University: collaborator

Study Sites (2)

Facualty of Pharmacy, Al Azhar University

Cairo, Cairo Governorate, 11765, Egypt

RECRUITING

Al-Ayen Univerisity

Madīnat Bābil, Babel, 51015, Iraq

RECRUITING

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Neveen Kohaf, ph.d

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neveen Kohaf, Ph.D

CONTACT

01060383012; nevenabdo@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: June 22, 2024
• First Posted: July 5, 2024
• Study Start (Estimated): July 12, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

IR (1); EG (1)