Using magnesium sulfate to reduce opioid use in children having laparoscopic appendectomy
The Effect of Intravenous Magnesium Infusion on the Opioid Consumption, the Circulatory, Metabolic and Hormonal Response to Intubation and Surgical Trauma During Anaesthesia for Laparoscopy in Children. Randomized Clinical Trial.
This study tests if giving magnesium sulfate through an IV can help reduce the amount of opioids kids need during laparoscopic appendectomy surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Months to 18 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT06563349 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of intravenous magnesium sulfate infusion as a co-analgesic in children undergoing laparoscopic appendectomy. It aims to assess its impact on opioid consumption and the physiological responses to anesthesia and surgical trauma. The study follows a multimodal approach to anesthesia, combining different methods and medications to minimize opioid use. The primary outcome is the measurement of opioid consumption during the procedure, while secondary outcomes include various intraoperative responses.
Who should consider this trial
Good fit: Ideal candidates are children classified as ASA physical status class 1E, 2E, or 3E who are scheduled for laparoscopic appendectomy.
Not a fit: Patients with allergies to magnesium sulfate, renal failure, or other specified medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid consumption in pediatric patients, leading to improved pain management and fewer side effects.
How similar studies have performed: While magnesium sulfate has shown promise in reducing analgesic consumption in some pediatric populations, high-quality randomized controlled trials specifically for laparoscopic appendectomy in children are still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency) * Patients undergoing laparoscopic appendectomy Exclusion Criteria: * Allergy to the magnesium sulfate or the excipient * Hypermagnesemia * Renal failure (GFR \<30 ml/min) * Myasthenia gravis * Preoperative atrioventricular block * Hypotension * The use of digitalis glycosides * The use of oral anticoagulants * ASA physical status class 4E or higher * Chronic treatment with analgesics * Legal guardians or patient refusal
Where this trial is running
Warsaw
- Uniwersity Clinic Centre of Medical Uniwersity of Warsaw — Warsaw, Poland (Recruiting)
Study contacts
- Study coordinator: Alicja Kuczerowska, MD
- Email: alicja.kuczerowska@uckwum.pl
- Phone: 601666694
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.