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

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Drug: Melatonin 3 MG; Other: Placebo

• Registration Number: NCT05728892
• Lead Sponsor: Ain Shams University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-25
• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-08-25
• Last Update Posted: 2024-08-27
• Primary Completion: 2024-12-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Melatonin 3 MG	patients undergoing abdominal surgery receiving melatonin
Group B	Placebo	control group

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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.

Trial Locations

Locations (1)

Ain shams university hospital; 🇪🇬 Cairo, Abbasia, Egypt