Magnesium Infusion for Pain Management in Critically Ill Trauma Patients

NCT04166877 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 1440730
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Keywords

magnesium sulfate; trauma; acute pain

Outcome Measures

Primary Outcomes (1)

• total opioid requirements during study drug infusion

  oral morphine equivalents, OME

  24 hours during study drug infusion

Secondary Outcomes (9)

• pain scores

  daily x 4 days

• Total oral morphine equivalents

  daily x 4 days

• ICU length of stay

  through the patient's hospitalization for this injury, an average of 10 days

• ICU-free days

  14 days

• Hospital length of stay

  through the patient's hospitalization for this injury, an average of 10 days

Study Arms (2)

Magnesium Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

The control arm will receive the same volume and rate of saline as if they were in the experimental group.

Drug: Normal saline placebo

Interventions

Magnesium Sulfate in Parenteral Dosage Form DRUG

IV bolus followed by continuous infusion for 24 hours

Magnesium Group

Normal saline placebo DRUG

IV bolus followed by continuous infusion for 24 hours

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

RECRUITING

Related Publications (12)

• Seo JW, Park TJ. Magnesium metabolism. Electrolyte Blood Press. 2008 Dec;6(2):86-95. doi: 10.5049/EBP.2008.6.2.86. Epub 2008 Dec 31.

  PMID: 24459527 BACKGROUND

• Upala S, Jaruvongvanich V, Wijarnpreecha K, Sanguankeo A. Hypomagnesemia and mortality in patients admitted to intensive care unit: a systematic review and meta-analysis. QJM. 2016 Jul;109(7):453-459. doi: 10.1093/qjmed/hcw048. Epub 2016 Mar 24.

  PMID: 27016536 BACKGROUND

• Albrecht E, Kirkham KR, Liu SS, Brull R. Peri-operative intravenous administration of magnesium sulphate and postoperative pain: a meta-analysis. Anaesthesia. 2013 Jan;68(1):79-90. doi: 10.1111/j.1365-2044.2012.07335.x. Epub 2012 Nov 1.

  PMID: 23121612 BACKGROUND

• Sousa AM, Rosado GM, Neto Jde S, Guimaraes GM, Ashmawi HA. Magnesium sulfate improves postoperative analgesia in laparoscopic gynecologic surgeries: a double-blind randomized controlled trial. J Clin Anesth. 2016 Nov;34:379-84. doi: 10.1016/j.jclinane.2016.05.006. Epub 2016 Jun 5.

  PMID: 27687417 BACKGROUND

• Hwang JY, Na HS, Jeon YT, Ro YJ, Kim CS, Do SH. I.V. infusion of magnesium sulphate during spinal anaesthesia improves postoperative analgesia. Br J Anaesth. 2010 Jan;104(1):89-93. doi: 10.1093/bja/aep334.

  PMID: 19933175 BACKGROUND

• Shariat Moharari R, Motalebi M, Najafi A, Zamani MM, Imani F, Etezadi F, Pourfakhr P, Khajavi MR. Magnesium Can Decrease Postoperative Physiological Ileus and Postoperative Pain in Major non Laparoscopic Gastrointestinal Surgeries: A Randomized Controlled Trial. Anesth Pain Med. 2013 Dec 6;4(1):e12750. doi: 10.5812/aapm.12750. eCollection 2014 Feb.

  PMID: 24660146 BACKGROUND

• Hamrick KL, Beyer CA, Lee JA, Cocanour CS, Duby JJ. Multimodal Analgesia and Opioid Use in Critically Ill Trauma Patients. J Am Coll Surg. 2019 May;228(5):769-775.e1. doi: 10.1016/j.jamcollsurg.2019.01.020. Epub 2019 Feb 21.

  PMID: 30797081 BACKGROUND

• 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.

  BACKGROUND

• Tramer MR, Schneider J, Marti RA, Rifat K. Role of magnesium sulfate in postoperative analgesia. Anesthesiology. 1996 Feb;84(2):340-7. doi: 10.1097/00000542-199602000-00011.

  PMID: 8602664 BACKGROUND

• Ozcan PE, Tugrul S, Senturk NM, Uludag E, Cakar N, Telci L, Esen F. Role of magnesium sulfate in postoperative pain management for patients undergoing thoracotomy. J Cardiothorac Vasc Anesth. 2007 Dec;21(6):827-31. doi: 10.1053/j.jvca.2006.11.013. Epub 2007 Feb 7.

  PMID: 18068060 BACKGROUND

• Lu JF, Nightingale CH. Magnesium sulfate in eclampsia and pre-eclampsia: pharmacokinetic principles. Clin Pharmacokinet. 2000 Apr;38(4):305-14. doi: 10.2165/00003088-200038040-00002.

  PMID: 10803454 BACKGROUND

• Jahnen-Dechent W, Ketteler M. Magnesium basics. Clin Kidney J. 2012 Feb;5(Suppl 1):i3-i14. doi: 10.1093/ndtplus/sfr163.

  PMID: 26069819 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Acute Pain

Interventions

Magnesium Sulfate; Injections

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Christine S Cocanour, MD

CONTACT

9167347330; cscocanour@ucdavis.edu

G J Jurkovich, MD

CONTACT

9167348298; gjjurkovich@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, investigator-initiated, randomized, double-blinded, placebo controlled study

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: December 7, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)