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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours during study drug infusion

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

total opioid requirements during study drug infusion

Secondary outcome measures

Development of bradycardia

Development of other dysrhythmia

Hospital length of stay

+6 more

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,363 Total Patients Enrolled

Media Library

Magnesium Sulfate (Electrolyte Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04166877 — Phase 4

Acute Pain Research Study Groups: Control Group, Magnesium Group

Acute Pain Clinical Trial 2023: Magnesium Sulfate Highlights & Side Effects. Trial Name: NCT04166877 — Phase 4

Magnesium Sulfate (Electrolyte Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04166877 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical ailments can be addressed by parenteral dosage forms of magnesium sulfate?

"Magnesium Sulfate in Parenteral Dosage Form is mostly prescribed to treat hypomagnesemia; however, it can also provide relief for other issues like poisoning and prophylaxis of contusions."

Answered by AI

What is the aggregate size of participants enrolled in this trial?

"Affirmative. According to clinicaltrials.gov, this healthcare research is currently recruiting subjects, having first been posted on December 7th 2019 and recently updated on May 16th 2022. It requires 156 people at a single site for the trial's completion."

Answered by AI

What research has been conducted on the efficacy of intramuscular administration of Magnesium Sulfate?

"Currently, 27 clinical trials are actively researching Magnesium Sulfate in Parenteral Dosage Form. Out of those studies, 8 have already reached the third phase of research and development. Locations for this drug examination range from Guangzhou to 42 other centers across the world."

Answered by AI

Is it possible to apply for this investigation at present?

"Affirmative. According to information on clinicaltrials.gov, this research initiative - which was first posted in December 2019 - is currently recruiting patients. 156 participants need to be enrolled from 1 medical centre."

Answered by AI

Has the FDA cleared Magnesium Sulfate in Parenteral Dosage Form for use?

"Due to this trial's Phase 4 status, signifying approval of the medication in question, our team at Power has given Magnesium Sulfate in Parenteral Dosage Form a score of 3 for safety."

Answered by AI

Recent research and studies

Anesthesiology and Pain MedicineJournal

Magnesium Can Decrease Postoperative Physiological Ileus and Postoperative Pain in Major Non Laparoscopic Gastrointestinal Surgeries: A Randomized Controlled Trial

Shariat Moharari, Reza, Majid Motalebi, Atabak Najafi, Mohammad Mahdi Zamani, Farsad Imani, Farhad Etezadi, Pejman Pourfakhr, and Mohammad Reza Khajavi. 2013. “Magnesium Can Decrease Postoperative Physiological Ileus and Postoperative Pain in Major Non Laparoscopic Gastrointestinal Surgeries: A Randomized Controlled Trial”. Anesthesiology and Pain Medicine. Briefland. doi:10.5812/aapm.12750.

Journal of Cardiothoracic and Vascular AnesthesiaJournal

Role of Magnesium Sulfate in Postoperative Pain Management for Patients Undergoing Thoracotomy

Ozcan, Perihan Ergin, Simru Tugrul, N. Mert Senturk, Elvan Uludag, Nahit Cakar, Lutfi Telci, and Figen Esen. 2007. “Role of Magnesium Sulfate in Postoperative Pain Management for Patients Undergoing Thoracotomy”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2006.11.013.

Journal of the American College of SurgeonsJournal

Multimodal Analgesia and Opioid Use in Critically Ill Trauma Patients

Hamrick, Kasey L., Carl A. Beyer, Jin A. Lee, Christine S. Cocanour, and Jeremiah J. Duby. 2019. “Multimodal Analgesia and Opioid Use in Critically Ill Trauma Patients”. Journal of the American College of Surgeons. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jamcollsurg.2019.01.020.

AnaesthesiaJournal