Magnesium Infusion for Trauma Pain Management

Overseen By G J Jurkovich, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Davis

Must not be taking: Opioids

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 24 hours

156 Participants Needed

Trial Summary

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. ^{2 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. ^{1 2 3 4 10}

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).

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

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

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

Signed informed consent

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.

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

Treatment Details

Interventions

• Magnesium Sulfate
• Normal saline placebo

Trial Overview 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.

Participant Groups

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 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

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

In a study of 64 patients undergoing hysterectomy, preoperative oral magnesium oxide significantly reduced postoperative pain compared to naproxen, as measured by the visual analogue scale (VAS).

Patients taking magnesium oxide also required lower doses of postoperative analgesics, indicating its potential for effective pain management with reduced medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of preoperative oral magnesium oxide on the severity of postoperative pain among women undergoing hysterectomy. Hashemian, M., Mirkheshti, A., Mirafzal, A., et al.[2022]

In a study involving 40 men undergoing prostate surgery, the use of magnesium sulfate (MgSO4) for wound infiltration significantly reduced the need for tramadol, a pain medication, compared to intravenous MgSO4 administration.

Both methods of MgSO4 delivery resulted in similar pain scores, indicating effective pain management without any observed side effects from either route of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. Tauzin-Fin, P., Sesay, M., Svartz, L., et al.[2018]

In a randomized clinical trial involving 30 female patients undergoing lower abdominal gynecological surgery, the administration of magnesium sulfate (MgSO4) significantly reduced postoperative analgesic consumption compared to a control group, indicating its effectiveness in pain management.

Patients receiving MgSO4 reported lower pain levels and required less pethidine for pain relief, suggesting that MgSO4 can enhance postoperative analgesia, although further research with larger samples is needed to confirm its safety and optimal dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of magnesium sulphate on postoperative analgesia requirements in gynecological surgeries. Asadollah, S., Vahdat, M., Yazdkhasti, P., et al.[2020]

In a study of 218 patients undergoing elective coronary artery bypass graft (CABG) surgery, intravenous magnesium sulfate (MgSO4) infusion significantly reduced post-operative pain scores and led to quicker extubation compared to a placebo.

Patients receiving MgSO4 reported lower pain levels at multiple time points (6, 12, 18, and 24 hours post-surgery) and required less morphine for pain management, indicating its efficacy in enhancing post-operative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of magnesium sulfate on extubation time and acute pain in coronary artery bypass surgery. Ferasatkish, R., Dabbagh, A., Alavi, M., et al.[2022]

In a study of 48 patients undergoing abdominal surgery, magnesium sulphate infusion significantly delayed the need for morphine post-surgery, with patients in the magnesium group waiting an average of 18 minutes compared to just 7 minutes in the placebo group.

Patients receiving magnesium sulphate also consumed significantly less morphine on the first postoperative day (30 mg vs 52 mg), and reported lower pain scores, indicating that magnesium sulphate is an effective adjuvant for managing postoperative pain without increasing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of intra and postoperative magnesium sulphate infusion on postoperative pain]. Benhaj Amor, M., Barakette, M., Dhahri, S., et al.[2013]

A survey of 954 Brazilian anesthesiologists revealed that 35.32% use magnesium sulfate in anesthesia, primarily for its benefits in postoperative analgesia, reducing anesthetic consumption, and managing preeclampsia and seizures.

While magnesium sulfate is generally safe with a low incidence of adverse events, the most common side effects reported were hypotension and residual neuromuscular blockade, highlighting the importance of monitoring during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use Profile of Magnesium Sulfate in Anesthesia in Brazil. Cavalcanti, IL., de Lima, FLT., da Silva, MJS., et al.[2020]

Magnesium sulfate (MgSO4) treatment in obstetrics has been associated with negative effects on the fetus and newborn, raising concerns about its safety in these populations.

There are conflicting reports regarding the tocolytic efficacy of magnesium sulfate, meaning its effectiveness in stopping preterm labor is still debated among researchers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. Mikołajek, W., Chlubek, D.[2017]

Magnesium sulfate is widely used in obstetrics for preventing seizures in women with preeclampsia and for stopping preterm labor, but it carries a risk of accidental overdose that can harm both mothers and babies.

Despite its routine use, vigilance is essential to ensure safety, and following the recommendations in this article can help reduce the risk of overdose and improve error detection before serious harm occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. Simpson, KR., Knox, GE.[2019]

In a study of 62 pregnant and postpartum women with severe preeclampsia, a maintenance dose of 1 gram/hour of magnesium sulfate was found to be as effective as 2 grams/hour in preventing eclampsia, with no cases of eclampsia reported in either group.

The 1 gram/hour regimen resulted in fewer side effects compared to the 2 gram/hour regimen, making it a safer option for maintaining serum magnesium levels while minimizing complications.

NCBI (Pubmed)

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. Pascoal, ACF., Katz, L., Pinto, MH., et al.[2022]

In a study of 70 patients undergoing brachial plexus block, magnesium sulfate infusion significantly increased the time to first pain and reduced total analgesic consumption compared to saline controls, indicating its efficacy in postoperative pain management.

The infusion did not affect the time to regain motor capability or sedation levels, suggesting that magnesium sulfate is a safe adjunct that can help manage pain without interfering with daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The postoperative analgesic effects of magnesium infusion on brachial plexus block]. Anbarci, O., Apan, A., Sahin, S.[2007]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

The effect of preoperative oral magnesium oxide on the severity of postoperative pain among women undergoing hysterectomy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. [2018]

3. Turkey pubmed.ncbi.nlm.nih.gov

The effect of magnesium sulphate on postoperative analgesia requirements in gynecological surgeries. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effect of magnesium sulfate on extubation time and acute pain in coronary artery bypass surgery. [2022]

5. Tunisia pubmed.ncbi.nlm.nih.gov

[Effect of intra and postoperative magnesium sulphate infusion on postoperative pain]. [2013]

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

Use Profile of Magnesium Sulfate in Anesthesia in Brazil. [2020]

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

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. [2017]

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

Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. [2019]

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]

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

[The postoperative analgesic effects of magnesium infusion on brachial plexus block]. [2007]