Opioid ConsumptionPhase 4NCT06563349
Magnesium Sulfate in Children Undergoing Laparoscopic Appendectomy
A Phase 4 study testing Intravenous magnesium sulfate and Normal saline infusion in people with Opioid Consumption and Multimodal Analgesia, run by Medical University of Warsaw at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Opioid Consumption, Multimodal Analgesia, Acute Appendicitis
- What is being tested?
- Intravenous magnesium sulfate and Normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 1 sitePoland
- Study dates
- 9 Sep 2024to 1 Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency)
- Patients undergoing laparoscopic appendectomy
Who cannot join
- Allergy to the magnesium sulfate or the excipient
- Hypermagnesemia
- Renal failure (GFR <30 ml/min)
- Myasthenia gravis
- Preoperative atrioventricular block
- Hypotension
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maciej Kaszyński, PhD contact
Poland1 site, 1 recruiting
- Recruiting
Uniwersity Clinic Centre of Medical Uniwersity of Warsaw
Warsaw, 02-091
Izabela Pągowska-Klimek, prof., izabela.pagowska-klimek@wum.edu.pl
Maciej Kaszyński, PhD
About this study
Official title: 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.
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.
Read the detailed description
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.
- Being tested
- Intravenous magnesium sulfate, Normal saline infusion
- Keywords
- multimodal analgesia, magnesium sulfate, laparoscopic appendectomy, children, pediatric population, adjuvant, metabolic stress response, hormonal response, inflammatory response
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous magnesium sulfateDrug
Also called IVM (intravenous magnesium)
Intraoperative intravenous magnesium sulfate infusion.
Normal saline infusionDrug
Also called Placebo
Intraoperative intravenous normal saline infusion.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulfate | Experimental | 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. Receives: Drug: Intravenous magnesium sulfate |
| Control | Placebo comparator | 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. Receives: Drug: Normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the beginning of magnesium sulfate application until transfer to the postanesthesia care unit (10 minutes after extubation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start9 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maciej Kaszyński, Medical University of Warsaw
- Investigators
- Izabela Pągowska-Klimek, prof., Study director, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563349
- Sponsor's protocol ID
- Mg01
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
Publications
Cettler M, Zielinska M, Rosada-Kurasinska J, Kubica-Cielinska A, Jarosz K, Bartkowska-Sniatkowska A. 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. Anaesthesiol Intensive Ther. 2022;54(3):197-218. doi: 10.5114/ait.2022.118972.
PubMed 36189904Benzon HA, Shah RD, Hansen J, Hajduk J, Billings KR, De Oliveira GS Jr, Suresh S. The Effect of Systemic Magnesium on Postsurgical Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial. Anesth Analg. 2015 Dec;121(6):1627-31. doi: 10.1213/ANE.0000000000001028.
PubMed 26501831O'Flaherty JE, Lin CX. Does ketamine or magnesium affect posttonsillectomy pain in children? Paediatr Anaesth. 2003 Jun;13(5):413-21. doi: 10.1046/j.1460-9592.2003.01049.x.
PubMed 12791115
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06563349
- Acronym / sponsor ID
- Mg01
- Keywords
- multimodal analgesia, magnesium sulfate, laparoscopic appendectomy, children, pediatric population, adjuvant, metabolic stress response, hormonal response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulfate | Experimental | Drug: Intravenous magnesium sulfate10% 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. |
| Control | Placebo comparator | Drug: Normal saline infusion0.9% 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. |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiologists) physical status class 1E, 2E, 3E (E - emergency)
- Patients undergoing laparoscopic appendectomy
Key exclusion criteria (11 listed)
- Allergy to the magnesium sulfate or the excipient
- Hypermagnesemia
- Renal failure (GFR <30 ml/min)
- Myasthenia gravis
- Preoperative atrioventricular block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous magnesium sulfateAlso: IVM (intravenous magnesium)Intraoperative intravenous magnesium sulfate infusion. | Drug | Magnesium Sulfate |
| Normal saline infusionAlso: PlaceboIntraoperative intravenous normal saline infusion. | Drug | Control |
Primary outcome
Number of patients requiring rescue dose of opioids.
Time frame: From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).
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.
7 secondary outcomes
The requirement for opioids during anesthesia
Time frame: From operating theatre admission through to postanesthesia care unit admission (10 minutes after extubation).
Hemodynamic reaction to tracheal intubation
Time frame: Pre-intubation - immediately after intubation.
Metabolic response to laparoscopic procedure
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
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
Time frame: From 5 minutes after tracheal intubation until the end of surgery, defined as the completion of dressing application.
Magnesium blood level
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
Time frame: From the beginning of magnesium sulfate application until transfer to the postanesthesia care unit (10 minutes after extubation).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 36189904Cettler M, Zielinska M, Rosada-Kurasinska J, Kubica-Cielinska A, Jarosz K, Bartkowska-Sniatkowska A. 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. Anaesthesiol Intensive Ther. 2022;54(3):197-218. doi: 10.5114/ait.2022.118972.
- Background: PubMed 26501831Benzon HA, Shah RD, Hansen J, Hajduk J, Billings KR, De Oliveira GS Jr, Suresh S. The Effect of Systemic Magnesium on Postsurgical Pain in Children Undergoing Tonsillectomies: A Double-Blinded, Randomized, Placebo-Controlled Trial. Anesth Analg. 2015 Dec;121(6):1627-31. doi: 10.1213/ANE.0000000000001028.
- Background: PubMed 12791115O'Flaherty JE, Lin CX. Does ketamine or magnesium affect posttonsillectomy pain in children? Paediatr Anaesth. 2003 Jun;13(5):413-21. doi: 10.1046/j.1460-9592.2003.01049.x.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the study will be available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maciej Kaszyński, PhD contact
Izabela Pągowska-Klimek, prof. study director
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous magnesium sulfate and Normal saline infusion in people with Opioid Consumption and Multimodal Analgesia, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alicja Kuczerowska, MD (601666694 ext. +48, alicja.kuczerowska@uckwum.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients requiring rescue dose of opioids. (time frame: From tracheal intubation through to postanesthesia care unit admission (10 minutes after extubation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563349, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.