NCT06489327 Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery
| NCT ID | NCT06489327 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Al-Azhar University |
| Condition | Preoperative Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-07-12 |
| Primary Completion | 2026-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-07-12 with a primary completion date of 2026-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Neveen Kohaf, ph.d
PRINCIPAL INVESTIGATOR
Al-Azhar University
Frequently Asked Questions
Who can join the NCT06489327 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 10 Years, studying Preoperative Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06489327 currently recruiting?
Yes, NCT06489327 is actively recruiting participants. Contact the research team at nevenabdo@azhar.edu.eg for enrollment information.
Where is the NCT06489327 trial being conducted?
This trial is being conducted at Cairo, Egypt, Madīnat Bābil, Iraq.
Who is sponsoring the NCT06489327 clinical trial?
NCT06489327 is sponsored by Al-Azhar University. The principal investigator is Neveen Kohaf, ph.d at Al-Azhar University. The trial plans to enroll 120 participants.
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