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Electrolyte Supplement

Magnesium Infusion for Trauma Pain Management

Phase 4

Recruiting

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All trauma patients admitted to an adult intensive care unit

Be older than 18 years old

Must not have

Greater than 5% TBSA burn injuries

Cardiac arrhythmia (except for sinus tachycardia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours during study drug infusion

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing whether magnesium sulfate can help control pain in trauma patients in the ICU, compared to normal saline.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Magnesium sulfate may cause side effects such as flushing (warmth and redness of your skin), sweating, upset stomach or diarrhea. In some cases it might also affect blood pressure or cause feelings of confusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My burns cover more than 5% of my body.

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

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I am on a constant opioid pain medication infusion.

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I am able to give my own consent for treatment.

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My kidney function is reduced (GFR below 60).

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I am admitted to the Pediatric Intensive Care Unit.

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I am following a treatment plan for moderate to severe alcohol withdrawal.

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My heart's pumping ability is significantly reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours during study drug infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours during study drug infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours during study drug infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

total opioid requirements during study drug infusion

Secondary study objectives

ICU-free days

Prevalence of Richmond Agitation-Sedation Scale of -3 to -5

Respiratory depression

+1 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 9Eligibility criteria met