A Phase 4 interventional study of Intravenous magnesium sulfate and Normal saline infusion in Opioid Consumption, Multimodal Analgesia and Acute Appendicitis, sponsored by Medical University of Warsaw. Recruiting at 1 site in Poland. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Supportive care
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.
Pain in the perioperative period is associated with surgical stimuli but also with laryngoscopy and intubation. According to the currently applicable ERAS (Enhanced Recovery After Surgery) doctrine, the recommended method of anesthesia is multimodal, low-opioid anesthesia. The essence of multimodal anesthesia is to combine different methods (e.g. general and regional anesthesia) and various anesthetic drugs in order to reduce the intraoperative use of opioids. The one of commonly used co-analgetic is magnesium. The use of magnesium infusion before induction of anesthesia may enhance the analgesic effect of the opioid administered before intubation. In current guidelines for the relief of acute pain in children, magnesium sulfate may be considered as a coanalgesic. It is based only on expert consensus opinion and/or data from small studies, retrospective studies, registries.
According to available data magnesium sulfate is superior to placebo in decreasing analgesic consumption and pain scores during the first 48 h after operation without any adverse effects in children with cerebral pals. In other groups of pediatric patients, the effectiveness of magnesium as a co-analgetic has not been proven. High quality randomized controlled trials are still missing.
The primary outcome of this study is to assess opioid consumption during the laparoscopic appendectomy. Number of patients requiring rescue dose of opioids will be measured.
The secondary aim is to examine total intraoperative fentanyl consumption, fluctuations of heart rate and blood pressure, metabolic, hormonal and inflammatory response (glucose, cortisol and IL-6 concentrations) and occurrence of side effects that may result from magnesium intake (decrease in blood pressure, bradycardia or allergic reaction).
In the pediatric population, the optimal perioperative magnesium dosage is 50 mg/kg as a bolus followed by an infusion of 15 mg/kg/hour until the end of the operation.
The general aim of the study is to evaluate the analgesic efficacy of intravenous magnesium sulfate as an adjunct to standard general anesthesia (involving intravenous induction and opioid with sevoflurane maintenance) for intubation and surgical trauma during anesthesia for laparoscopic appendectomy in children.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 188 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10% magnesium sulfate intravenous bolus of 0.5 ml/kg (maximum 20 ml) over 5 min before induction of anesthesia followed by magnesium sulfate infusion at 0.15 ml/kg/h (maximum 6 ml/h) intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
Drug: Intravenous magnesium sulfate
0.9% NaCl (sodium chloride) intravenous bolus of 0.5 ml/kg (maximum 20 ml) over 5 min before induction of anesthesia followed by 0.9% NaCl infusion at 0.15 ml/kg/h (maximum 5ml/h) intraoperatively will be administered. The infusion will be discontinued before the patients' transfer to the postanesthesia care unit.
Drug: Normal saline infusion
Intraoperative intravenous magnesium sulfate infusion.
Also known as: IVM (intravenous magnesium)
Intraoperative intravenous normal saline infusion.
Also known as: Placebo
Number of patients requiring rescue dose of opioids.
Patients who experience a 20% increase in BP (Blood Pressure) or HR (Heart Rate) from baseline during surgery and the early post-extubation period will receive a bolus of fentanyl (1 mcg/kg) as rescue analgesia. The number of these patients will be compared between the groups. Baseline parameters will be recorded after premedication with an IV bolus of 0.05 mg/kg midazolam, just before intubation.
Time frame: From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).
The requirement for opioids during anesthesia
Total amount of fentanyl in micrograms per kilogram of body weight used during anesthesia (dose for induction of anesthesia + doses added during surgery and in the early post-extubation period).
Time frame: From operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).
Hemodynamic reaction to tracheal intubation
A change in arterial blood pressure of more than 20% from baseline will be noted, and the fractions of these patients in each group will be compared. Baseline parameters will be recorded after premedication with an IV bolus of 0.05 mg/kg midazolam, just before intubation.
Time frame: Pre-intubation - immediately after intubation.
Metabolic response to laparoscopic procedure
Glucose \[mg/dl\] levels will be measured and compared before and after laparoscopic procedure. The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application.
Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
Hormonal response to laparoscopic procedure
Cortisol levels \[mcg/dl\] will be measured and compared before and after laparoscopic procedure. The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application.
Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
Inflammatory response to laparoscopic procedure
IL-6 levels \[pg/ml\] will be measured and compared before and after laparoscopic procedure. The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application.
Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
Magnesium blood level
Magnesium level \[mg/dl\] will be measured after initial bolus and just before the end of its infusion. The first blood sample will be taken 5 minutes after tracheal intubation, before the skin incision. The second blood sample will be taken immediately after the end of surgery, at the time of dressing application. Magnesium infusion will be discontinued after the second blood sample is collected.
Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
Side effects of magnesium sulfate
Side effects of magnesium sulfate will be assessed by recording the rates of the following complications: hypotension \& bradycardia (both defined as 2 SD (standard deviation) below the 50th percentile for age), allergic reaction. Need to discontinue the magnesium sulfate/placebo infusion due to side effects. Need to administer calcium gluconate.
Time frame: From the beginning of magnesium sulfate application until transfer to the postanesthesia care unit (10 minutes after extubation).
Length of stay in the hospital after completing anesthesia
Length of stay in the hospital after completing anesthesia is defined as the time period from extubation (endotracheal tube removal) to discharge from the hospital. The mean length of hospital stay in the control and study groups will be compared.
Time frame: From the time of extubation until the time of discharge from the hospital, through study completion, an average of 3 days.
Plan to share: Yes — The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
Supporting information: Study protocol, Clinical study report
Time frame: The study protocol will be available to other researchers continuously after its publication. The Clinical Study Report will be published after the study completion.
Access criteria: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
Started Sep 2024 (actual). Primary completion is estimated for Sep 2027, 35 months after the start.
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Studies of the drug tested here: Magnesium
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