Intravenous Magnesium Sulfate to Reduce Opioid Use and Manage Pain During Laparoscopic Appendectomy in Children
Led by Medical University of Warsaw · Updated on 2024-11-12
188
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating how intravenous magnesium sulfate infusion affects opioid use and the bodys circulatory, metabolic, and hormonal responses during anesthesia for laparoscopic appendectomy in children. Magnesium has antinociceptive and anti-inflammatory effects and is commonly used as a co-analgesic in adults. However, its effectiveness in children lacks strong scientific evidence, and this study aims to provide high-quality data on its use in pediatric surgery.
The study compares two groups one receiving magnesium sulfate as an intravenous bolus before anesthesia induction followed by continuous infusion during surgery, and the other receiving a placebo of normal saline in the same manner. The magnesium dose is 50 mgkg as a bolus and 15 mgkghour during the operation. The infusion stops before the patient is moved to the postanesthesia care unit.
Participants will be monitored from tracheal intubation through postanesthesia care unit admission, with measurements including opioid consumption, heart rate and blood pressure changes, metabolic and hormonal markers glucose, cortisol, IL-6, magnesium blood levels, and any side effects such as low blood pressure or allergic reactions. The primary outcome is the number of patients needing rescue opioid doses. Secondary outcomes include detailed intraoperative opioid use and physiological responses. The study will last until October 2027.
CONDITIONS
Brief Title
Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
Research Team
A
Alicja Kuczerowska, MD
M
Maciej Kaszyński, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
ASA physical status class 1E, 2E, or 3E (emergency)
Patients scheduled for laparoscopic appendectomy
You will not qualify if you...
Allergy to magnesium sulfate or its excipients
Hypermagnesemia
Renal failure with GFR less than 30 ml/min
Myasthenia gravis
Preoperative atrioventricular block
Hypotension
Use of digitalis glycosides
Use of oral anticoagulants
ASA physical status class 4E or higher
Chronic treatment with analgesics
Refusal by patient or legal guardians
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of the laparoscopic appendectomy surgery
Participants receive intravenous magnesium sulfate or placebo infusion during anesthesia for laparoscopic appendectomy to evaluate opioid use and body responses to surgery.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 10 minutes after extubation
Participants are monitored for opioid use, side effects of magnesium sulfate, and recovery during transfer to the postanesthesia care unit.
1 postanesthesia care visit (in-person)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Study of Risks and Outcomes in Adults Needing Emergency Surgery at Skne University Hospital
Acutelines Biobank to Improve Early Detection and Personalized Treatment of Acute Diseases
Tracking Patient Outcomes from Emergency Admissions
Using AI-driven Virtual Pediatric Patients to Improve Primary Healthcare Doctors Skills in Managing Common Childhood Diseases in China
Comparing Ultrasound-Guided and Landmark-Guided Dorsal Penile Nerve Blocks for Pain Relief in Boys Undergoing Circumcision
Study Comparing Two Patient-Controlled Analgesia Methods for Postoperative Pain Management
Variable-Rate Feedback Infusion Versus Fixed-Rate Basal Infusion After Mixed Surgery
Study of CT Scan and AIR Score Impact on Negative Appendectomy in Adults
Undergoing Surgery for Suspected Acute Appendicitis
Study Comparing Two Patient-Controlled Analgesia Methods for Pain Management After Various Surgeries
Fixed-rate Basal Infusion vs Time-programmed Decremental Infusion Modes
Aiming to Reduce Opioid Use and Improve Recovery
Comparing Rhomboid Intercostal Block and Serratus Posterior Superior Intercostal Plane Block for Pain Relief After Video-Assisted Thoracic Surgery in Adults
Continuous Nefopam Infusion Compared to Lidocaine and Epidural Analgesia for Pain and Opioid Reduction After Pancreatoduodenectomy Surgery
Comparing Preoperative and Intraoperative Erector Spinae Plane Block to Reduce Opioid and Anesthetic Use in Lumbar Disc Herniation Surgery
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Guidelines for treatment of acute pain in children - the consensus statement of the Section of Paediatric Anaesthesiology and Intensive Therapy of the Polish Society of Anaesthesiology and Intensive Therapy.
Maciej Cettler, Marzena Zielińska, Jowita Rosada-Kurasińska...