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no difference found between two groups in a preliminary analysis
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The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.
Patients with severe headaches often come to the emergency department seeking relief from their symptoms. There is some dating suggesting that over the counter treatment options are not inferior to treatment options offered in emergency departments. Patients presenting to the Einstein Emergency Department with IHS criteria for migraine headache will be approached by research associate and offered to participate in a randomized double blind study comparing excedrin migraine to compazine. Patients will be randomized by the hospital pharmacy. The pharmacy will distribute one of two packets, one containing prochlorperazine 10mg and 2 placebo tablets, the other containing 2 generic AAC tablets without scoring (acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet) and a placebo syringe. Patients will be monitored for improvement of pain, change in vital signs, and adverse events for two hours after receiving drugs. At 24 hours, the patients will be called back to access if they experienced any side effects from the time of discharge, and if they would take this medicine again if they experienced another migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin, Acetaminophen, Caffeine pills | Active Comparator | Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline. |
|
| Prochlorperazine 10mg | Active Comparator | Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin, Acetaminophen, Caffeine pills | Drug | One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference From Baseline of VAS Pain Scores | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | 60 minutes from drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Reported Adverse Side-effects | Secondary endpoints will also be assessed at 30min, 90min and 120min. Additional secondary endpoints will be in the number of reported adverse side-effects, defined as muscle spasm, tiredness, extreme restlessness, GI upset, vomiting in the ED and treatment failure rate. | 30, 90, and 120 minutes from drug administration |
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Inclusion Criteria:
18 years or older
Headache must meet the IHS criteria for migraine or probable migraine
2 out of 4 of following:
During HA, at least 1 out of 3 of following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Deitch, DO | Albert Einstein Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
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0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin, Acetaminophen, Caffeine Pills | Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline. Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV) |
| FG001 | Prochlorperazine 10mg | Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin, Acetaminophen, Caffeine Pills | Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline. Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| 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 | Mean Difference From Baseline of VAS Pain Scores | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | 60 minutes from drug administration |
|
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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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 | Aspirin, Acetaminophen, Caffeine Pills | Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline. Aspirin, Acetaminophen, Caffeine pills: One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV) |
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0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kamran Mohiuddin, Director Clinical Research Emergency Department | EINSTEIN MEDICAL CENTER | 2154562313 | MOHIUDDK@EINSTEIN.EDU |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000082 | Acetaminophen |
| C110820 | acetaminophen, aspirin, caffeine drug combination |
| D011346 | Prochlorperazine |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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|
| Prochlorperazine 10mg | Drug | One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. |
|
|
| BG001 | Prochlorperazine 10mg | Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Prochlorperazine 10mg |
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. |
|
| Secondary | Number of Reported Adverse Side-effects | Secondary endpoints will also be assessed at 30min, 90min and 120min. Additional secondary endpoints will be in the number of reported adverse side-effects, defined as muscle spasm, tiredness, extreme restlessness, GI upset, vomiting in the ED and treatment failure rate. | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available | Posted | 30, 90, and 120 minutes from drug administration |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Prochlorperazine 10mg | Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |