NCT03617289

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2023

Completed
Last Updated

March 24, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

August 1, 2018

Results QC Date

August 4, 2018

Last Update Submit

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

EXPERIMENTAL

Receiving Magnesium Sulfate

Drug: Magnesium Sulfate

Placebo

PLACEBO COMPARATOR

Receiving Dextrose 5% in Water (D5W)

Drug: D5W

Interventions

Treatment
D5WDRUG
Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Renal Colic

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

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