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Analgesic and Antioxidant Effects of Melatonin in Pediatric Surgery

NCT06724432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-12-17

No results posted yet for this study

Summary

Background. Long-term consequences of postoperative pain are detrimental in children. We tested the hypothesis that melatonin reduces postoperative pain and oxidative stress involving sirtuin pathway in children undergoing surgery.

Methods. Thirty-one children were randomly assigned to oral supplementation with melatonin or placebo, before surgery. Plasma levels of 4-hydroxynonenal (4-HNE), melatonin, sirtuin 1 (SIRT1), and circulating miR-34 and miR-124a were analyzed at T0 (pre-hospitalization), T1 (before surgery), and T2 (1 h after the end of the surgery).

Conditions

  • Postoperative Pain
  • Oxidative Stress Response

Interventions

DRUG

oral melatonin

Melatonin treated children receive a single dose of oral melatonin 0.5 mg/kg (for a max 10 mg) in a fixed volume of 5 mL of water , 1 hour before induction of anesthesia for surgery

DRUG

Placebo

Children in the Control group receive 5 ml of 5% dextrose solution once 1 hour before induction of anesthesia

Sponsors & Collaborators

  • University of Messina

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • University of Siena

    collaborator OTHER

  • University of Urbino "Carlo Bo"

    collaborator OTHER

  • University of Parma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2023-06-01
Completion
2024-09-01

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724432 on ClinicalTrials.gov