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

Not Applicable

Completed

• Conditions: Renal Colic
• Interventions: Drug: D5W; Drug: Magnesium Sulfate

• Registration Number: NCT03617289
• Lead Sponsor: Henry Ford Health System

Brief Summary

To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2018-08-01
• Study First Submitted QC: 2018-08-03
• Results First Submitted: 2018-08-04
• Study First Posted: 2018-08-06
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Results First Posted: 2023-03-24
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	D5W	Receiving Dextrose 5% in Water (D5W)
Treatment	Magnesium Sulfate	Receiving Magnesium Sulfate

Primary Outcome Measures

Name	Time	Method
Pain Score Change	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.

Secondary Outcome Measures

Name	Time	Method
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	We analyzed how many patients required additional pain control with opiates between the two treatment groups.