Renal ColicNCT03617289
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
A study testing Magnesium Sulfate and D5W in people with Renal Colic, run by Henry Ford Health System.
Trial summary
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Colic
- What is being tested?
- Magnesium Sulfate and D5W
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
About this study
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.
- Conditions
- Renal Colic
- Being tested
- Magnesium Sulfate, D5W
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
D5WDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Receiving Magnesium Sulfate Receives: Drug: Magnesium Sulfate |
| Placebo | Placebo comparator | Receiving Dextrose 5% in Water (D5W) Receives: Drug: D5W |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour after the completion of treatment medication (Placebo or Study Drug)
Secondary outcomes (1)
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.
Measured: Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Muir, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617289
- Sponsor's protocol ID
- 10080
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2018
- Last updated
- 24 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
- ClinicalTrials.gov ID
- NCT03617289
- Acronym / sponsor ID
- 10080
- Conditions
- Renal Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 24 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Magnesium SulfateReceiving Magnesium Sulfate |
| Placebo | Placebo comparator | Drug: D5WReceiving Dextrose 5% in Water (D5W) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate | Drug | Treatment |
| D5W | Drug | Placebo |
Primary outcome
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 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and D5W in people with Renal Colic, run by Henry Ford Health System.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Change (time frame: 1 hour after the completion of treatment medication (Placebo or Study Drug)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.