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

Ain Shams University

Status: Enrolling

Conditions: Postoperative Pain

Treatments: Other: Placebo; Drug: Melatonin 3 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05728892

FAMSU R264/2022

Details and patient eligibility

About

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

Enrollment: 72 estimated patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

patients undergoing abdominal surgery receiving melatonin

Treatment:

Drug: Melatonin 3 MG

Group B

Placebo Comparator group

Description:

control group

Treatment:

Other: Placebo