Magnesium Infusion for Pain Management in Critically Ill Trauma Patients

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT04166877
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Pain
  • Trauma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnesium Sulfate in Parenteral Dosage Form — DRUG
    IV bolus followed by continuous infusion for 24 hours
  • Normal saline placebo — DRUG
    IV bolus followed by continuous infusion for 24 hours

Study Details

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).

Key Dates

Start date
Dec 7, 2019
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Magnesium Group
    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.
  • Placebo Comparator: Control Group
    The control arm will receive the same volume and rate of saline as if they were in the experimental group.

Primary Outcome Measure

total opioid requirements during study drug infusion [ Time Frame: 24 hours during study drug infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis HealthSacramentoCalifornia95817
Christine S Cocanour, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UC Davis Health· Sacramento, CA

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