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To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Receiving Magnesium Sulfate |
|
| Placebo | Placebo Comparator | Receiving Dextrose 5% in Water (D5W) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium Sulfate | Drug |
| ||
| D5W |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Receiving 15mg ketorolac IV push plus 2g Magnesium Sulfate in 100ml of D5W over 1 hour via pump |
| FG001 | Placebo | Receiving 15mg ketorolac IV push plus dextrose 5% in water (D5W) 100ml over 1 hour via pump |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Receiving Magnesium Sulfate Magnesium Sulfate |
| BG001 | Placebo | Receiving D5W D5W |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a Scale | 1 hour after the completion of treatment medication (Placebo or Study Drug) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Receiving Magnesium Sulfate Magnesium Sulfate |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Muir | Henry Ford Health System | 517-861-6451 | jmuir1@hfhs.org |
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| ID | Term |
|---|---|
| D056844 | Renal Colic |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008278 | Magnesium Sulfate |
| ID | Term |
|---|---|
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
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|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 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. | Posted | Number | percentage of participants | Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug |
|
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Placebo | Receiving D5W D5W | 0 | 19 | 0 | 19 |
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| D013456 |
| Sulfur Acids |
| D013457 | Sulfur Compounds |