Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
1 other identifier
interventional
72
1 country
1
Brief Summary
To study the role of Preoperative Melatonin adminsteration in pediatric patients undergoing laparoscopic surgeries regarding its analgesic and sedative effects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jan 2023
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 25, 2023
CompletedFirst Submitted
Initial submission to the registry
January 26, 2023
CompletedFirst Posted
Study publicly available on registry
February 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedAugust 27, 2024
February 1, 2024
1.9 years
January 26, 2023
August 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Group A
ACTIVE COMPARATORpatients undergoing abdominal surgery receiving melatonin
Group B
PLACEBO COMPARATORcontrol group
Interventions
Preopertive melatonin adminstration oral 0.2 mg /kg 45 min before general anaethesia.
Eligibility Criteria
You may qualify if:
- Age from 2 to 10 years.
- Sex: Both sexes.
- Patients with ASA classificaion I and II.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams university hospital
Cairo, Abbasia, 11213, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2023
First Posted
February 15, 2023
Study Start
January 25, 2023
Primary Completion
December 30, 2024
Study Completion
May 30, 2025
Last Updated
August 27, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share