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Magnesium Infusion for Pain Management in Critically Ill Trauma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04166877
Recruitment Status : Not yet recruiting
First Posted : November 18, 2019
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Christine S. Cocanour, University of California, Davis

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).


Condition or disease Intervention/treatment Phase
Trauma Acute Pain Drug: Magnesium Sulfate in Parenteral Dosage Form Drug: Normal saline placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, investigator-initiated, randomized, double-blinded, placebo controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium Infusion for Pain Management in Critically Ill Trauma Patients
Estimated Study Start Date : November 25, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Magnesium Sulfate in Parenteral Dosage Form
IV bolus followed by continuous infusion for 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.
Drug: Normal saline placebo
IV bolus followed by continuous infusion for 24 hours




Primary Outcome Measures :
  1. total opioid requirements during study drug infusion [ Time Frame: 24 hours during study drug infusion ]
    oral morphine equivalents, OME


Secondary Outcome Measures :
  1. pain scores [ Time Frame: daily x 4 days ]
    numeric pain rating scale as reported by patient

  2. Total oral morphine equivalents [ Time Frame: daily x 4 days ]
  3. ICU length of stay [ Time Frame: through the patient's hospitalization for this injury, an average of 10 days ]
  4. ICU-free days [ Time Frame: 14 days ]
    14 days minus the number of ICU days

  5. Hospital length of stay [ Time Frame: through the patient's hospitalization for this injury, an average of 10 days ]
  6. Development of bradycardia [ Time Frame: 24 hours during study drug infusion ]
  7. Development of other dysrhythmia [ Time Frame: 24 hours during study drug infusion ]
  8. Respiratory depression [ Time Frame: 24 hours during study drug infusion ]
    Episodes of respiratory depression as measured by a respiratory rate less than 8

  9. Prevalence of Richmond Agitation-Sedation Scale of -3 to -5 [ Time Frame: 24 hours during study drug infusion ]
    Episodes of a -3 to -5 Richmond Agitation-Sedation Scale score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Publications:
Williamson M. A., Snyder L. M., Wallach J. B. Wallach's Interpretation of Diagnostic Tests. 9th. Philadelphia, PA, USA: Wolters Kluwer/Lippincott Williams & Wilkins; 2011. xvi, 1143.

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Responsible Party: Christine S. Cocanour, Professor of Surgery, University of California, Davis
ClinicalTrials.gov Identifier: NCT04166877    
Other Study ID Numbers: 1440730
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Christine S. Cocanour, University of California, Davis:
magnesium sulfate
trauma
acute pain
Additional relevant MeSH terms:
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Acute Pain
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents