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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnesium sulfate, administered through an IV, can help control pain for trauma patients in the Intensive Care Unit. Magnesium may reduce the need for narcotic pain relievers, providing a non-narcotic option for pain management. The trial compares the effects of magnesium sulfate to a saline solution to determine which is more effective. It seeks trauma patients in the ICU who are part of a hospital pain management plan and can provide consent. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for magnesium sulfate?

Research has shown that magnesium sulfate is generally safe and effective for managing pain. It has reduced pain before and after surgeries, suggesting it might also benefit ICU patients with injuries.

Hospitals already use magnesium sulfate to treat low magnesium levels, so its safety is well-established. However, like any treatment, it can have side effects. Some reports mention slight harm if inhaled or if it contacts the skin, but this is uncommon in medical use.

Overall, healthcare has used magnesium sulfate for many purposes, and safety data supports its use. This trial aims to determine if it is a good option for managing pain in trauma patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard pain management options for trauma, which often rely on opioids, magnesium sulfate offers a different approach by acting as a calcium antagonist and NMDA receptor blocker. This means it can potentially reduce pain and inflammation without the risk of addiction and side effects associated with opioids. Researchers are excited about magnesium sulfate because it might not only offer effective pain control but also do so with fewer side effects, providing a safer alternative for managing trauma pain.

What evidence suggests that magnesium sulfate is effective for trauma pain management?

Studies have shown that magnesium sulfate effectively manages pain, especially post-surgery. Research indicates it reduces the need for narcotics, which are strong pain relievers. This reduction is important because fewer narcotics lead to fewer side effects for patients. Evidence suggests magnesium works by blocking certain pain signals in the body. In this trial, participants in the Magnesium Group will receive magnesium infusions. Previous studies reported that patients receiving magnesium infusions experienced less pain and fewer complications. This makes magnesium sulfate a promising option for controlling pain in trauma patients in the ICU. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Pregnancy

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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 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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8143286/

Magnesium for Pain Treatment in 2021? State of the Art - PMC Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04166877

Magnesium Infusion for Pain Management in Critically Ill ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7468697/

Magnesium and Pain - PMC - PubMed Central - NIH Jarahzadeh et al. reported that the intravenous use of magnesium sulfate (50 mg/kg) could provide effective analgesia and reduce requirement and adverse events ...

4. ijhsr.org ijhsr.org/IJHSR_Vol.13_Issue.9_Sep2023/IJHSR21.pdf

A Comparative Study to Assess the Effectiveness of Epsom ... Results: revealed Epsom salt with hot water effectively reduced pain and improved function. ... Epsom salt, a water-soluble magnesium sulfate with.

5. cureus.com cureus.com/articles/221482-magnesium-sulfate-and-its-versatility-in-anesthesia-a-comprehensive-review.pdf

Magnesium Sulfate and Its Versatility in Anesthesia MgSO4's adaptable qualities present a viable path for improving anesthetic outcomes, possibly improving patient safety and improving surgical ...

6. labelsds.com labelsds.com/images/user_uploads/Premier%20Mag%20Sulfate%20SDS%202-20-20.pdf

SAFETY DATA SHEET At very high temperatures, magnesium oxide, sulfur dioxide and sulfur trioxide may be generated. No known chronic hazards. Not listed by NTP, ...

7. flinnsci.com flinnsci.com/sds_480.1-magnesium-sulfate/sds_480.1/?srsltid=AfmBOorEDntnhJCU5k3KPS2nu6I4POTbFkBK6AG3nzXa7dCyjvTdQH9z

Magnesium Sulfate Safety Data Sheet (SDS) Hazard class: Acute toxicity, inhalation and dermal (Category 5). May be harmful if inhaled or in contact with skin (H313+H333).

8. fivestarchemicals.com fivestarchemicals.com/mwdownloads/download/link/id/494

magnesium sulfate magnesium sulfate. Safety Data Sheet according to Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules and Regulations. Date of ...

9. www2.atmos.umd.edu www2.atmos.umd.edu/~russ/MSDS/magnesium_sulfate_anhydrous.htm

MAGNESIUM SULFATE ANHYDROUS Emergency Overview -------------------------- CAUTION! MAY BE HARMFUL IF SWALLOWED. J.T. Baker SAF-T-DATA(tm) Ratings (Provided here for ...