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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05728892
Collaborator
(none)
72
1
2
4.1
17.5

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Melatonin 3 MG
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
Actual Study Start Date :
Jan 25, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain shams university hospital Cairo Abbasia Egypt 11213

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ain Shams University
ClinicalTrials.gov Identifier:
NCT05728892
Other Study ID Numbers:
  • FAMSU R264/2022
First Posted:
Feb 15, 2023
Last Update Posted:
Feb 15, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2023