Comparing two doses of oral melatonin to reduce anxiety in children before surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.