Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
1 other identifier
interventional
37
0 countries
N/A
Brief Summary
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2016
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 1, 2018
CompletedFirst Posted
Study publicly available on registry
August 6, 2018
CompletedResults Posted
Study results publicly available
March 24, 2023
CompletedMarch 24, 2023
February 1, 2023
4 months
August 1, 2018
August 4, 2018
February 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 hour after the completion of treatment medication (Placebo or Study Drug)
Secondary Outcomes (1)
Percentage of Participants Requiring Opiates for Additional Pain Control
Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug
Study Arms (2)
Treatment
EXPERIMENTALReceiving Magnesium Sulfate
Placebo
PLACEBO COMPARATORReceiving Dextrose 5% in Water (D5W)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jason Muir
- Organization
- Henry Ford Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 1, 2018
First Posted
August 6, 2018
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
May 1, 2016
Last Updated
March 24, 2023
Results First Posted
March 24, 2023
Record last verified: 2023-02