156 Participants Needed

Magnesium Infusion for Trauma Pain Management

CS
GJ
Overseen ByG J Jurkovich, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, Davis
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.26789

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.123410

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.
See 11 more

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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium GroupExperimental Treatment1 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 GroupPlacebo Group1 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

Find a Clinic Near You

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

References

The effect of preoperative oral magnesium oxide on the severity of postoperative pain among women undergoing hysterectomy. [2022]
Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. [2018]
The effect of magnesium sulphate on postoperative analgesia requirements in gynecological surgeries. [2020]
Effect of magnesium sulfate on extubation time and acute pain in coronary artery bypass surgery. [2022]
[Effect of intra and postoperative magnesium sulphate infusion on postoperative pain]. [2013]
Use Profile of Magnesium Sulfate in Anesthesia in Brazil. [2020]
[Efficiency and safety of magnesium sulfate treatment in obstetrics]. [2017]
Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. [2019]
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]
[The postoperative analgesic effects of magnesium infusion on brachial plexus block]. [2007]
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