Renal Colic
Conditions
Brief summary
To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.
Interventions
DRUGMagnesium Sulfate
DRUGD5W
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Receiving Magnesium Sulfate
Magnesium Sulfate | 18 |
| Placebo Receiving D5W
D5W | 19 |
| Total | 37 |
Baseline characteristics
| Characteristic | Treatment | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 19 Participants | 37 Participants |
| Region of Enrollment United States | 18 participants | 19 participants | 37 participants |
| Sex: Female, Male Female | 9 Participants | 11 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 18 | 0 / 19 |
| serious Total, serious adverse events | 0 / 18 | 0 / 19 |
Outcome results
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.
Time frame: 1 hour after the completion of treatment medication (Placebo or Study Drug)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Pain Score Change | -3.4 Units on a Scale | Standard Deviation 2.7 |
| Placebo | Pain Score Change | -3.6 Units on a Scale | Standard Deviation 3.9 |
p-value: 0.771Wilcoxon (Mann-Whitney)
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.
Time frame: Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Percentage of Participants Requiring Opiates for Additional Pain Control | 16.7 percentage of participants |
| Placebo | Percentage of Participants Requiring Opiates for Additional Pain Control | 47.4 percentage of participants |
p-value: <0.046Chi-squared