Migraine
Conditions
Brief summary
Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.
Detailed description
Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge
Interventions
DRUGmetoclopramide
metoclopramide 20 mg
DRUGDiphenhydramine 25mg
Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* acute migraine
Exclusion criteria
* secondary cause of headache * lumbar puncture * allergy or intolerance to study medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score | Baseline, 60 minutes | Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Metoclopramide 10 mg Intravenous Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous | 113 |
| Metoclopramide 20 mg Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous | 118 |
| Metoclopramide 40 mg Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous | 118 |
| Total | 349 |
Baseline characteristics
| Characteristic | Metoclopramide 10 mg Intravenous | Metoclopramide 20 mg | Metoclopramide 40 mg | Total |
|---|---|---|---|---|
| Age, Continuous Adults | 38.7 years STANDARD_DEVIATION 11.5 | 37.5 years STANDARD_DEVIATION 9.9 | 38.4 years STANDARD_DEVIATION 12 | 38.2 years STANDARD_DEVIATION 11.1 |
| Sex: Female, Male Female | 94 Participants | 103 Participants | 97 Participants | 294 Participants |
| Sex: Female, Male Male | 19 Participants | 15 Participants | 21 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 113 | 8 / 118 | 7 / 118 |
| serious Total, serious adverse events | 0 / 113 | 1 / 118 | 0 / 118 |
Outcome results
Primary
Pain Intensity Score
Change in 11 point pain intensity score between baseline and one hour. At both baseline and one hour, all patients were asked to describe their pain on a scale from 0 to 10, with 0 signifying no pain and 10 signifying the worst pain imaginable. Therefore, the CHANGE in pain score could range from -10 through 10.
Time frame: Baseline, 60 minutes
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Metoclopramide 10 mg Intravenous | Pain Intensity Score | 4.7 scores on a scale | Standard Deviation 2.6 |
| Metoclopramide 20 mg | Pain Intensity Score | 4.9 scores on a scale | Standard Deviation 2.8 |
| Metoclopramide 40 mg | Pain Intensity Score | 5.3 scores on a scale | Standard Deviation 2.8 |