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

Ain Shams University72 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postoperative Pain

Interventions

Melatonin 3 MGDRUG

Preopertive melatonin adminstration oral 0.2 mg /kg 45 min before general anaethesia.

PlaceboOTHER

Placebo medication will be given to control group

Eligibility

Sex: ALLMin age: 2 YearsMax age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Ain shams university hospital

Cairo, Abbasia, Egypt

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Discharge from postanesthesia care unit (1 hour)

Central Contacts

Mohamed A Tolba, MD

CONTACT

01156622298 Mohamedtolba@med.asu.edu.eg

Diaaeldein M Haiba

CONTACT

01006516286

Data from ClinicalTrials.gov

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