Comparing two doses of oral melatonin to reduce anxiety in children before surgery
Comparing Two Doses of Oral Melatonin as Premedication in Children Undergoing Surgery: A Double-Blind Randomized Trial
This study is testing if two different doses of melatonin can help reduce anxiety in children aged 4 to 14 before they have surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 4 Years to 10 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 2 sites (Cairo, Cairo Governorate and 1 other locations) |
| Trial ID | NCT06489327 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of two different doses of oral melatonin as a premedication to alleviate preoperative anxiety in children aged 4 to 14 years undergoing elective surgeries. Participants will be randomly assigned to receive either a low dose (0.2 mg/kg), a high dose (0.4 mg/kg) of melatonin, or a placebo. The study will assess the levels of anxiety experienced by the children prior to surgery, comparing the outcomes across the different groups. The goal is to determine if melatonin can serve as a safer alternative to traditional anxiolytics like midazolam.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 4 to 14 years who are scheduled for elective surgeries and have a physical status classified as ASA I or II.
Not a fit: Patients with ASA physical status greater than III, drug allergies, or gastrointestinal disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and effective method to reduce preoperative anxiety in pediatric patients.
How similar studies have performed: Previous studies have shown that melatonin can effectively reduce anxiety in various populations, suggesting potential success for this approach in pediatric patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cairo, Cairo Governorate and 1 other locations
- Facualty of Pharmacy, Al Azhar University — Cairo, Cairo Governorate, Egypt (Recruiting)
- Al-Ayen Univerisity — Madīnat Bābil, Babel, Iraq (Recruiting)
Study contacts
- Principal investigator: Neveen Kohaf, ph.d — Al-Azhar University
- Study coordinator: Neveen Kohaf, Ph.D
- Email: nevenabdo@azhar.edu.eg
- Phone: 01060383012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.