Actively Recruiting

Phase Not Applicable
Age: 4Years - 10Years
All Genders
NCT06489327

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

Led by Al-Azhar University · Updated on 2026-01-06

120

Participants Needed

2

Research Sites

22 weeks

Total Duration

On this page

Sponsors

A

Al-Azhar University

Lead Sponsor

A

Al-Ayen Iraqi University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 4Years - 10Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of either sex
  • Age from 4 to 14 years
  • Patients with American Society Anesthesiologist physical status I and II
  • Patients undergoing elective surgeries
Not Eligible

You will not qualify if you...

  • American Society Anesthesiologist physical status more than III
  • Drug allergy
  • Gastrointestinal disorders

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Facualty of Pharmacy, Al Azhar University

Cairo, Cairo Governorate, Egypt, 11765

Actively Recruiting

2

Al-Ayen Univerisity

Madīnat Bābil, Babel, Iraq, 51015

Actively Recruiting

Loading map...

Research Team

N

Neveen Kohaf, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here