Trial Outcomes & Findings for Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department (NCT NCT03617289)
NCT ID: NCT03617289
Last Updated: 2023-03-24
Results Overview
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.
COMPLETED
NA
37 participants
1 hour after the completion of treatment medication (Placebo or Study Drug)
2023-03-24
Participant Flow
Participant milestones
| Measure |
Treatment
Receiving 15mg ketorolac IV push plus 2g Magnesium Sulfate in 100ml of D5W over 1 hour via pump
|
Placebo
Receiving 15mg ketorolac IV push plus dextrose 5% in water (D5W) 100ml over 1 hour via pump
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Baseline characteristics by cohort
| Measure |
Treatment
n=18 Participants
Receiving Magnesium Sulfate
Magnesium Sulfate
|
Placebo
n=19 Participants
Receiving D5W
D5W
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
37 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Treatment
n=18 Participants
Receiving 15mg ketorolac IV push plus 2g magnesium sulfate in 100ml D5W infused over 1 hour via pump
Magnesium Sulfate
|
Placebo
n=19 Participants
Receiving 15mg ketorolac IV push plus 100ml D5W infuse over 1 hour via pump
D5W
|
|---|---|---|
|
Pain Score Change
|
-3.4 Units on a Scale
Standard Deviation 2.7
|
-3.6 Units on a Scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drugWe analyzed how many patients required additional pain control with opiates between the two treatment groups.
Outcome measures
| Measure |
Treatment
n=18 Participants
Receiving 15mg ketorolac IV push plus 2g magnesium sulfate in 100ml D5W infused over 1 hour via pump
Magnesium Sulfate
|
Placebo
n=18 Participants
Receiving 15mg ketorolac IV push plus 100ml D5W infuse over 1 hour via pump
D5W
|
|---|---|---|
|
Percentage of Participants Requiring Opiates for Additional Pain Control
|
16.7 percentage of participants
|
47.4 percentage of participants
|
Adverse Events
Treatment
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place