Back to resultsEfficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Primary Purpose
Renal Colic
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnesium Sulfate
D5W
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic
Eligibility Criteria
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 delerium or altered mental status.
- Patients with inability to consent to study or inability to fill questionnaire independently.
- Patients with CKD 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
Receiving Magnesium Sulfate
Receiving Dextrose 5% in Water (D5W)
Outcomes
Primary Outcome Measures
Pain Score Change
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.
Secondary Outcome Measures
Percentage of Participants Requiring Opiates for Additional Pain Control
We analyzed how many patients required additional pain control with opiates between the two treatment groups.
Full Information
NCT ID
NCT03617289
First Posted
August 1, 2018
Last Updated
February 28, 2023
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT03617289
Brief Title
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Official Title
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
5. Study Description
Brief Summary
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Receiving Magnesium Sulfate
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Receiving Dextrose 5% in Water (D5W)
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Type
Drug
Intervention Name(s)
D5W
Primary Outcome Measure Information:
Title
Pain Score Change
Description
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.
Time Frame
1 hour after the completion of treatment medication (Placebo or Study Drug)
Secondary Outcome Measure Information:
Title
Percentage of Participants Requiring Opiates for Additional Pain Control
Description
We analyzed how many patients required additional pain control with opiates between the two treatment groups.
Time Frame
Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
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