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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes |
|
| 2 | Experimental | metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes. |
|
| 3 | Experimental | metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoclopramide | Drug | metoclopramide 20 mg |
| |
| metoclopramide |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin W. Friedman, MD, MS | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide 10 mg Intravenous | Metoclopramide 10 mg intravenous + diphenhydramine 25mg intravenous |
| FG001 | Metoclopramide 20 mg Intravenous | Metoclopramide 20 mg intravenous+ diphenhydrmaine 25 mg intravenous |
| FG002 | Metoclopramide 40 mg Intravenous | Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Emergency Department Portion |
| |||||||||||||
| 48 Hour Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide 10 mg Intravenous | Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous |
| BG001 | Metoclopramide 20 mg | Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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. | per protocol | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 60 minutes |
|
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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 | Metoclopramide 10 mg Intravenous | Metoclopramide 10 mg intravenous + diphenhydramine 25 mg intravenous |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalitis | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman | Montefiore Medical Center | 718 920 6626 | befriedm@montefiore.org |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Drug |
metoclopramide 40 mg |
|
| metoclopramide | Drug | metoclopramide 10 mg |
|
| Diphenhydramine 25mg | Drug | Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes |
|
| NOT COMPLETED |
|
| BG002 | Metoclopramide 40 mg | Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | Metoclopramide 40 mg | Metoclopramide 40mg intravenous + diphenhdyramine 25mg intravenous |
|
|
| 0 |
| 113 |
| 8 |
| 113 |
| EG001 | Metoclopramide 20 mg | Metoclopramide 20mg intravenous+ diphenhydrmaine 25 mg intravenous | 1 | 118 | 8 | 118 |
| EG002 | Metoclopramide 40 mg | Metoclopramide 40 mg intravenous + diphenhdyramine 25 mg intravenous | 0 | 118 | 7 | 118 |
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| D009422 | Nervous System Diseases |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |