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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05728892
Other study ID # FAMSU R264/2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 25, 2023
Est. completion date May 30, 2024

Study information

Verified date February 2023
Source Ain Shams University
Contact Mohamed A Tolba, MD
Phone 01156622298
Email Mohamedtolba@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the role of Preoperative Melatonin adminsteration in pediatric patients undergoing laparoscopic surgeries regarding its analgesic and sedative effects


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date May 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 10 Years
Eligibility Inclusion Criteria: - Age from 2 to 10 years. - Sex: Both sexes. - Patients with ASA classificaion I and II. Exclusion Criteria: - Declining to give written informed consent. - History of allergy to the medications used in the study. - psychiatric disorder. - ASA classification III-V. - Fever ,cough , asthma or upper respiratory tract infection, neuromuscular disorders, spine abnormalities. - Anticipated difficult airway . - History of malignant hyperthermia

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Melatonin 3 MG
Preopertive melatonin adminstration oral 0.2 mg /kg 45 min before general anaethesia.
Other:
Placebo
Placebo medication will be given to control group

Locations

Country Name City State
Egypt Ain shams university hospital Cairo Abbasia

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain Assesment of pain will be done using Face, Leg, Activity , Crying and Consolability behavioural pain scale (FLACC), Each category is scored on the 0-2 scale, which results in a total score of 0-10.
0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain and 7-10 = Severe discomfort or pain or both.
Discharge from postanesthesia care unit (1 hour)
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