Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- American Society Anesthesiologist physical status more than III
- Drug allergy
- Gastrointestinal disorders
AI-Screening
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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
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
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