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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Melatonin 3 MG; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed A Tolba, MD; Phone Number: 01156622298; Email: Mohamedtolba@med.asu.edu.eg
• Study Contact Backup: Name: Diaaeldein M Haiba; Phone Number: 01006516286

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt, 11213
      • Recruiting
      • Ain Shams University Hospital
      • Contact: Sherif Wadei, MD; Phone Number: 01156622298

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; patients undergoing abdominal surgery receiving melatonin	Drug: Melatonin 3 MG; Preopertive melatonin adminstration oral 0.2 mg /kg 45 min before general anaethesia.
Placebo Comparator: Group B; control group	Other: Placebo; Placebo medication will be given to control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: January 26, 2023
• First Submitted That Met QC Criteria: February 12, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 27, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Protective Agents; Antioxidants; Melatonin
• Other Study ID Numbers: FAMSU R264/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No