Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.

Ain Shams University1 site in 1 country72 target enrollmentJanuary 25, 2023

ConditionsPostoperative Pain

InterventionsMelatonin 3 MG Placebo

DrugsMelatonin 3 MG

Overview

Phase: Not Applicable
Intervention: Melatonin 3 MG
Conditions: Postoperative Pain
Sponsor: Ain Shams University
Enrollment: 72
Locations: 1
Primary Endpoint: Postoperative pain
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 25, 2023

End Date

May 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ain Shams University

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Group A

patients undergoing abdominal surgery receiving melatonin

Intervention: Melatonin 3 MG

Group B

control group

Intervention: Placebo

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: Discharge from postanesthesia care unit (1 hour)

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.