Trial Outcomes & Findings for Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines (NCT NCT05967442)
NCT ID: NCT05967442
Last Updated: 2024-10-08
Results Overview
Scores range from 0-10. A higher score, denotes more pain
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
157 participants
Primary outcome timeframe
30 minutes after initiation
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
Magnesium
Magnesium Sulfate: Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
|
Metoclopramide
Metoclopramide 10mg in 50ml D5W over 20 minutes
Metoclopramide 10mg: Metoclopramide 10mg in 50ml D5W over 20 minutes
|
Prochlorperazine
Prochlorperazine in 50ml D5W over 20 minutes
Prochlorperazine (Compazine) Injection: Prochlorperazine 10mg in 50ml D5W over 20 minutes
|
|---|---|---|---|
|
Overall Study
STARTED
|
61
|
44
|
52
|
|
Overall Study
COMPLETED
|
61
|
44
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Magnesium Versus Prochlorperazine Versus Metoclopramide for Migraines
Baseline characteristics by cohort
| Measure |
Magnesium
n=61 Participants
Magnesium Sulfate: Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
|
Metoclopramide
n=44 Participants
Metoclopramide 10mg in 50ml D5W over 20 minutes
Metoclopramide 10mg: Metoclopramide 10mg in 50ml D5W over 20 minutes
|
Prochlorperazine
n=52 Participants
Prochlorperazine in 50ml D5W over 20 minutes
Prochlorperazine (Compazine) Injection: Prochlorperazine 10mg in 50ml D5W over 20 minutes
|
Total
n=157 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
37.5 years
n=7 Participants
|
37.5 years
n=5 Participants
|
36 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
136 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after initiationPopulation: Full cohort
Scores range from 0-10. A higher score, denotes more pain
Outcome measures
| Measure |
Magnesium
n=61 Participants
Magnesium Sulfate: Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
|
Metoclopramide
n=44 Participants
Metoclopramide 10mg in 50ml D5W over 20 minutes
Metoclopramide 10mg: Metoclopramide 10mg in 50ml D5W over 20 minutes
|
Prochlorperazine
n=52 Participants
Prochlorperazine in 50ml D5W over 20 minutes
Prochlorperazine (Compazine) Injection: Prochlorperazine 10mg in 50ml D5W over 20 minutes
|
|---|---|---|---|
|
30 Minute Pain Score
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: From time of arrival to time of discharge.Emergency Department Length of stay. Measured from time of arrival to time of discharged documented in the electronic medical record.
Outcome measures
| Measure |
Magnesium
n=61 Participants
Magnesium Sulfate: Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
|
Metoclopramide
n=44 Participants
Metoclopramide 10mg in 50ml D5W over 20 minutes
Metoclopramide 10mg: Metoclopramide 10mg in 50ml D5W over 20 minutes
|
Prochlorperazine
n=52 Participants
Prochlorperazine in 50ml D5W over 20 minutes
Prochlorperazine (Compazine) Injection: Prochlorperazine 10mg in 50ml D5W over 20 minutes
|
|---|---|---|---|
|
Length of Stay
|
325 minutes
Interval 274.0 to 410.0
|
308 minutes
Interval 263.5 to 403.0
|
332 minutes
Interval 268.5 to 391.0
|
SECONDARY outcome
Timeframe: From time of arrival to time of discharge.Percentage of participants who had necessity for rescue analgesics after study drug administration
Outcome measures
| Measure |
Magnesium
n=61 Participants
Magnesium Sulfate: Magnesium Sulfate 2gm in 50ml D5W over 20 minutes
|
Metoclopramide
n=44 Participants
Metoclopramide 10mg in 50ml D5W over 20 minutes
Metoclopramide 10mg: Metoclopramide 10mg in 50ml D5W over 20 minutes
|
Prochlorperazine
n=52 Participants
Prochlorperazine in 50ml D5W over 20 minutes
Prochlorperazine (Compazine) Injection: Prochlorperazine 10mg in 50ml D5W over 20 minutes
|
|---|---|---|---|
|
Need for Rescue Analgesia
|
26 Participants
|
15 Participants
|
17 Participants
|
Adverse Events
Magnesium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Metoclopramide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prochlorperazine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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