Recruiting

Magnesium Infusion

Sponsor:

UCLA

Code:

NCT04166877

Conditions

Trauma

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium Sulfate in Parenteral Dosage Form

Normal saline placebo

Study Details

Brief summary:

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).

Conditions

Trauma

Acute Pain

Study ID

NCT04166877

Start date

Dec 7, 2019

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All trauma patients admitted to an adult intensive care unit
  • Signed informed consent
  • Hospital or trauma multimodal pain management order set used for pain management
  • Ages 18-99

Exclusion Criteria:

  • Admission to the Pediatric Intensive Care Unit.
  • Head Abbreviated Injury Score (AIS) of greater than 1
  • Known heart failure with reduced ejection fraction (EF < 40%)
  • Renal failure (GFR < 60)
  • Cardiac arrhythmia (except for sinus tachycardia)
  • Greater than 5% TBSA burn injuries
  • Moderate to severe alcohol withdrawal protocol ordered for patient
  • Regular use of opioids in the week prior to injury
  • Receiving continuous infusion of opioids
  • Patients expected to require general anesthesia between 24 and 48 hours after admission (during study drug administration)
  • Patients unable to provide consent is unavailable
  • Patients unable to provide a pain score
  • Pregnancy
  • Prisoners

Study Design

Enrollment

156 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Magnesium Sulfate in Parenteral Dosage Form

IV bolus followed by continuous infusion for 24 hours

Normal saline placebo

IV bolus followed by continuous infusion for 24 hours

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Christine S Cocanour, MD

9167347330cscocanour@ucdavis.edu

G J Jurkovich, MD

9167348298gjjurkovich@ucdavis.edu

Locations

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

Principal Investigator:

Christine S Cocanour, MD

More Information

Sponsor

University of California, Davis

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

  • magnesium sulfate
  • trauma
  • acute pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2025-11-26.