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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728892
• Other study ID #: FAMSU R264/2022
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

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)