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

NCT ID: NCT05728892

Last Updated: 2024-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-25

Study Completion Date

2025-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

patients undergoing abdominal surgery receiving melatonin

Group Type ACTIVE_COMPARATOR

Melatonin 3 MG

Intervention Type DRUG

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

Group B

control group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo medication will be given to control group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Melatonin 3 MG

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

Intervention Type DRUG

Placebo

Placebo medication will be given to control group

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ain shams university hospital

Cairo, Abbasia, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mohamed A Tolba, MD

Role: CONTACT

01156622298

Diaaeldein M Haiba

Role: CONTACT

01006516286

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sherif Wadei, MD

Role: primary

01156622298

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FAMSU R264/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Personalizing Perioperative Analgesia in Children
NCT01140724 ACTIVE_NOT_RECRUITING
Pain Control Without Opioids
NCT04813991 WITHDRAWN PHASE3