Acute Pain > Magnesium Sulfate

Magnesium Infusion for Trauma Pain Management

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of California, Davis

Must not be taking: Opioids

Disqualifiers: Heart failure, Renal failure, Arrhythmia, Pregnancy, others

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?

Magnesium is a naturally occurring mineral that is important for your body and brain. Magnesium sulfate (study drug) is a medication containing magnesium that is commonly used to improve low blood levels of magnesium. Magnesium sulfate has also proven to be successful in managing pain before and after surgery. However, this drug has primarily been used for pain control in patients undergoing surgery. Patients in the ICU with injuries also need good pain control. Using magnesium may assist in decreasing narcotic (pain reliever) requirements and provide another non-narcotic drug for pain control. The purpose of this study is to test the effectiveness of continuous, intravenous (into or within a vein using a needle) administration of magnesium sulfate for pain control in trauma patients admitted to the adult Intensive Care Unit. This will be compared to intravenous normal saline (salt solution).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you regularly use opioids or are receiving continuous opioid infusions, you may not be eligible to participate.

What data supports the effectiveness of the drug Magnesium Sulfate for trauma pain management?

Research shows that Magnesium Sulfate can reduce pain and the need for painkillers after surgeries, such as abdominal and gynecological operations, which suggests it might help with trauma pain too.

^{1 2 3 4 5}

Is magnesium sulfate safe for use in humans?

Magnesium sulfate is generally considered safe when used at recommended doses, but it can cause side effects like low blood pressure, muscle weakness, and high magnesium levels in the blood. It is important to monitor for these effects, especially in settings like anesthesia and obstetrics where it is commonly used.

^{3 6 7 8 9}

How does the drug magnesium sulfate differ from other treatments for trauma pain management?

Magnesium sulfate is unique because it can be administered as an infusion to reduce the need for other pain medications after surgery, potentially leading to fewer side effects and complications. It works by affecting the body's response to pain and reducing the need for additional painkillers.

^{2 3 4 5 10}

Eligibility Criteria

This trial is for adult trauma patients (18-99 years old) in the ICU who can consent to participate and are on a hospital-approved pain management plan. It's not for those with severe head injuries, heart failure, renal failure, alcohol withdrawal, expected anesthesia within 24-48 hours post-admission, unable to report pain, pregnant women, prisoners or regular opioid users.

Inclusion Criteria

I am between 18 and 99 years old.

My pain is managed using a hospital's comprehensive plan.

I am a trauma patient in an adult intensive care unit.

Exclusion Criteria

My burns cover more than 5% of my body.

I have a heart rhythm problem that is not sinus tachycardia.

I am on a constant opioid pain medication infusion.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive a continuous intravenous infusion of magnesium sulfate or placebo for pain control

24 hours

Continuous monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days

Daily monitoring

Participant Groups

The study tests if intravenous magnesium sulfate can better manage pain in critically ill trauma patients compared to a saline placebo. The goal is to see if magnesium reduces the need for narcotics and offers an alternative non-narcotic pain control method.

Group I: Magnesium Group Experimental Treatment 1 Intervention

The magnesium group arm will receive a 40 mg/kg IBW (maximum 4 g) bolus of intravenous magnesium sulfate, followed by a continuous infusion of 0.5 g/hr for a total of 24 hours.

Group II: Control Group Placebo Group 1 Intervention

The control arm will receive the same volume and rate of saline as if they were in the experimental group.

Magnesium Sulfate is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment
• Constipation treatment

🇪🇺 Approved in European Union as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

🇨🇦 Approved in Canada as Magnesium sulfate for:

• Seizure prevention in pre-eclampsia
• Asthma exacerbation treatment

🇦🇺 Approved in Australia as Magnesium sulphate for:

• Pre-eclampsia and eclampsia treatment
• Hypomagnesemia treatment

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UC Davis Health Sacramento, CA

Who Is Running the Clinical Trial?

University of California, Davis Lead Sponsor

References

1. Tunisia pubmed.ncbi.nlm.nih.gov

[Effect of intra and postoperative magnesium sulphate infusion on postoperative pain]. [2013] Evaluate the effect of intra and postoperative magnesium sulphate infusion on postoperative pain in abdominal surgery.

2. Ireland pubmed.ncbi.nlm.nih.gov

The effect of preoperative oral magnesium oxide on the severity of postoperative pain among women undergoing hysterectomy. [2022] Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic, and endocrine reflexes provoked by noxious stimuli. The pre-emptive analgesic effects of magnesium in reducing postoperative pain could be beneficial in abdominal and gynecologic surgeries.

3. England pubmed.ncbi.nlm.nih.gov

Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. [2018] This prospective, randomized, double-dummy study was undertaken to compare the effects of magnesium sulphate (MgSO(4)) administered by the intravenous vs. the infiltration route on postoperative pain and analgesic requirements.

4. Turkey pubmed.ncbi.nlm.nih.gov

The effect of magnesium sulphate on postoperative analgesia requirements in gynecological surgeries. [2020] Recent studies have shown the positive effect of magnesium sulphate (MgSO4) on pain reduction and postoperative analgesic requirements in patients undergoing surgery. We assessed the effect of MgSO4 on intra-operative and postoperative analgesic requirements in patients undergoing lower abdominal gynecological laparotomy.

5. England pubmed.ncbi.nlm.nih.gov

Effect of magnesium sulfate on extubation time and acute pain in coronary artery bypass surgery. [2022] Post-operative pain control is one of the greatest concerns for both physicians and patients. In this study, the effect of magnesium sulfate (MgSO(4)) solution infusion on post-operative pain scores and extubation time in patients undergoing elective coronary artery bypass graft (CABG) surgeries was assessed.

6. Switzerland pubmed.ncbi.nlm.nih.gov

Use Profile of Magnesium Sulfate in Anesthesia in Brazil. [2020] Objectives: The use of magnesium sulfate in the perioperative period has several benefits, including analgesia, inhibition of the release of catecholamines and prevention of vasospasm. The aim of this survey was to provide an overview of the use of magnesium sulfate in anesthesia. Method: This was a prospective descriptive cross-sectional study. An online questionnaire was sent to 9,869 Brazilian anesthesiologists and trainees. The questionnaire comprised closed questions mainly regarding the frequency, clinical effects, adverse events, and doses of magnesium sulfate used in anesthesia. Results: Of the 954 doctors who responded to the survey, 337 (35.32%) reported using magnesium sulfate in anesthesia. The most commonly cited clinical effects for the use of magnesium sulfate in anesthesia were (n/%): postoperative analgesia (245/72.70%), reduction of anesthetic consumption (240/71.21%) and prevention and treatment of preeclampsia and seizures in eclampsia (220/65.28%). The most frequently reported adverse events were hypotension (187/55.48%), residual neuromuscular blockade (133/39.46%), hypermagnesemia (30/8.90%), and intravenous injection pain (26/7.71%). The intravenous doses of magnesium sulfate used in most general anesthesia inductions were between 30 and 40 mg.kg-1. Conclusions: Magnesium sulfate is an important adjuvant drug in the practice of anesthesia, with several clinical effects and a low incidence of adverse events when used at recommended doses.

7. Poland pubmed.ncbi.nlm.nih.gov

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. [2017] Current views on efficacy and safety of magnesium sulfate treatment in obstetrics are presented. Negative effects of MgSO4 on fetus and newborn are described. Contradictory reports dealing with tocolytic efficacy of magnesium sulfate are discussed.

8. United States pubmed.ncbi.nlm.nih.gov

Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. [2019] Magnesium sulfate is commonly used in obstetrical practice both as seizure prophylaxis in women with preeclampsia, as well as to inhibit preterm labor contractions. However, despite (and perhaps because of) years of use and provider familiarity, the administration of magnesium sulfate occasionally results in accidental overdose and patient harm. Fortunately, in most instances when potentially fatal amounts of magnesium sulfate are given, the error is recognized before permanent adverse outcomes occur. Nevertheless, a significant and sometimes unappreciated risk of harm to mothers and babies continues to exist. Intravenous magnesium sulfate treatment has become routine practice in obstetrics, but this does not lessen the vigilance required for safe care for mothers and babies. Implementation of the recommendations provided in this article will promote patient safety and decrease the likelihood of an accidental overdose, as well as increase the chances of identifying an error before a significant adverse outcome occurs.

9. United States pubmed.ncbi.nlm.nih.gov

Serum magnesium levels during magnesium sulfate infusion at 1 gram/hour versus 2 grams/hour as a maintenance dose to prevent eclampsia in women with severe preeclampsia: A randomized clinical trial. [2022] Magnesium sulfate is the ideal drug for the prevention and treatment of eclampsia. Nevertheless, the best regimen for protection against eclampsia with minimal side effects remains to be established. This study aimed to compare serum magnesium levels during intravenous infusion of magnesium sulfate at 1 gram/hour versus 2 grams/hour as a maintenance dose to prevent eclampsia in pregnant and postpartum women with severe preeclampsia.

10. Turkey pubmed.ncbi.nlm.nih.gov

[The postoperative analgesic effects of magnesium infusion on brachial plexus block]. [2007] Magnesium sulphate infusion decreases analgesic requirements after general anesthesia. Aim of this study was to assess the effects of postoperative magnesium infusion for 24 hours on duration of the block, sedation and postoperative analgesic consumption after brachial plexus block. After obtaining approval from local ethic committee, 70 ASA class I and II patients were included to the randomised double blind study. Brachial plexus block was performed using axillary approach with lignocaine 1.25% adrenaline 1/200 000 40 ml. Groups received 5 mg/kg bolus and 500 mg/h magnesium sulphate infusion or saline controls at the same volume during 24 hour. Analgesia and sedation were assessed while determining time to first pain and rescue analgesic, time to regain motor capability, visual analogue scale and sedation scores for every 4 hour during postoperative 24 h. period. While time to first pain and rescue analgesic was increased, total analgesic consumption was reduced significantly on magnesium infusion group (Meperidine: C: 36.3 +/- 42.6 mg, Mg: 11.7 +/- 12.2 mg, p: 0.001). Visual analogue scales were also observed to be lower in all periods. Time to motor block resolution, and sedation scores were similar. Magnesium sulphate infusion is thought as a safe and suitable adjunct for reducing analgesic consumption and possible complications without interfering daily activity in patients undergoing brachial plexus block.