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RecruitingNCT05728892Updated Aug 27, 2024

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

An interventional study of Melatonin 3 MG and Placebo in Postoperative Pain, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
2 Years to 10 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 72 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age from 2 to 10 years.
  • Sex: Both sexes.
  • Patients with ASA classificaion I and II.

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (estimated)

Study arms

  • Active comparator
    Group A

    patients undergoing abdominal surgery receiving melatonin

    Drug: Melatonin 3 MG

  • Placebo comparator
    Group B

    control group

    Other: Placebo

Interventions

  • DrugMelatonin 3 MG

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

  • OtherPlacebo

    Placebo medication will be given to control group

06

What researchers measure

Primary outcomes

  1. 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)

07

Study locations

1 of 1 sites recruiting
  • Ain shams university hospital
    Cairo, Abbasia 11213, Egypt
    • Sherif Wadei, MD · Contact · 01156622298
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05728892
Lead sponsor
Ain Shams University
Responsible party
Sponsor
First posted
Feb 15, 2023
Start date
Jan 25, 2023
Primary completion
Dec 30, 2024 (estimated)
Completion
May 30, 2025 (estimated)
Last update
Aug 27, 2024

Study contacts

Mohamed A Tolba, MD
Contact
Mohamedtolba@med.asu.edu.eg
01156622298
Diaaeldein M Haiba
Contact
01006516286

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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