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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05728892
Enrollment
72
Registered
2023-02-15
Start date
2023-01-25
Completion date
2025-05-30
Last updated
2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Brief summary

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

Interventions

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

OTHERPlacebo

Placebo medication will be given to control group

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative painDischarge 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.

Countries

Egypt

Contacts

Primary ContactMohamed A Tolba, MD
Mohamedtolba@med.asu.edu.eg01156622298
Backup ContactDiaaeldein M Haiba
01006516286

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026