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Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy

NCT06563349 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-11-12

No results posted yet for this study

Summary

Magnesium sulfate is one of the most commonly used co-analgetics. Its antinociceptive effect is related to antagonizing NMDA (N-methyl-D-aspartate) receptors of the nervous system, has an anti-inflammatory effect by reducing the concentration of IL-6 (interleukin 6) and tumor necrosis factor alpha. In adult patients, the need for morphine in the perioperative period is reduced when magnesium infusion is used. In current guidelines for treatment of acute pain in children, magnesium sulfate may be considered as a co-analgetic. However, the strength of such a recommendation is low due to the lack of reliable scientific research confirming the effectiveness of magnesium infusion in the pediatric population. The aim of this study is to evaluate the efficacy of intravenous magnesium sulfate infusion on the opioid consumption, the circulatory, metabolic and hormonal response to intubation and surgical trauma during anesthesia for laparoscopic appendectomy in children.

Conditions

  • Opioid Consumption
  • Multimodal Analgesia
  • Acute Appendicitis
  • Complication of Treatment

Interventions

DRUG

Intravenous magnesium sulfate

Intraoperative intravenous magnesium sulfate infusion.

DRUG

Normal saline infusion

Intraoperative intravenous normal saline infusion.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Izabela Pągowska-Klimek, prof. · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-09
Primary Completion
2027-09-01
Completion
2027-10-01

Countries

  • Poland

Study Locations

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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 NCT06563349 on ClinicalTrials.gov