Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department

February 28, 2023 updated by: Jason Muir, Henry Ford Health System
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years old and <100 years old.
  • Patients seen in the Emergency Department at Henry Ford Macomb hospital.
  • Patients that are A+Ox3.
  • Patients who have typical presentation for renal colic.

Exclusion Criteria:

  • Age <18 years.
  • Patients with a history of dementia, acute delirium or altered mental status.
  • Patients with inability to consent to study or inability to fill questionnaire independently.
  • Patients with chronic kidney disease and allergies to study drugs.
  • Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG).
  • Patients with stroke activation or symptoms.
  • Patients with trauma activations.
  • Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age.
  • Imaging study does not show evidence of ureteral stone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Receiving Magnesium Sulfate
Drug: Magnesium Sulfate
Placebo Comparator: Placebo
Receiving Dextrose 5% in Water (D5W)
Drug: D5W

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score Change
Time Frame: 1 hour after the completion of treatment medication (Placebo or Study Drug)
We asked the patient's pain score on a scale of 0-10 with 10 being the highest amount of pain and 0 no pain, before and after treatment (approximately 1 hour). Primary Outcome was the change in score before and after treatment.
1 hour after the completion of treatment medication (Placebo or Study Drug)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Requiring Opiates for Additional Pain Control
Time Frame: Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug
We analyzed how many patients required additional pain control with opiates between the two treatment groups.
Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 1, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10080 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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