NCT05728892RecruitingNot Applicable
Melatonin and Its Effect on the Perioperative Opioid Needs in Pediatric Patients Undergoing Laparoscopic Surgery.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Postoperative pain
Study Overview
Brief Summary
To study the role of Preoperative Melatonin adminsteration in pediatric patients undergoing laparoscopic surgeries regarding its analgesic and sedative effects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 10 Years (Child)
- Sex
- 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
Arms & Interventions
Group A
Active Comparator
patients undergoing abdominal surgery receiving melatonin
Intervention: Melatonin 3 MG (Drug)
Group B
Placebo Comparator
control group
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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