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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Melatonin 3 MG

Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

2 Years - 10 Years (Child)All SexesAccepts 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

Sites / Locations

Ain shams university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

patients undergoing abdominal surgery receiving melatonin

control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05728892

First Posted

January 26, 2023

Last Updated

February 12, 2023

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT05728892

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 25, 2023 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Product Manufactured in and Exported from the U.S.

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Active Comparator

Arm Description

patients undergoing abdominal surgery receiving melatonin

Arm Title

Group B

Arm Type

Placebo Comparator

Arm Description

control group

Intervention Type

Drug

Intervention Name(s)

Melatonin 3 MG

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo medication will be given to control group

Primary Outcome Measure Information:

Title

Postoperative pain

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed A Tolba, MD

Phone

01156622298

Email

Mohamedtolba@med.asu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Diaaeldein M Haiba

Phone

01006516286

Facility Information:

Facility Name

Ain shams university hospital

City

Cairo

State/Province

Abbasia

ZIP/Postal Code

11213

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherif Wadei, MD

Phone

01156622298

12. IPD Sharing Statement

Plan to Share IPD

No

Postoperative Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial