Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine (Migraine)
|ClinicalTrials.gov Identifier: NCT01629329|
Recruitment Status : Terminated (no difference found between two groups in a preliminary analysis)
First Posted : June 27, 2012
Last Update Posted : June 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headaches||Drug: Aspirin, Acetaminophen, Caffeine pills Drug: Prochlorperazine 10mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: 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.
Drug: 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)
Other Name: Excedrin
Active Comparator: Prochlorperazine 10mg
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
Drug: Prochlorperazine 10mg
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
Other Name: Compazine
- Mean difference from baseline of VAS pain scores [ Time Frame: 60 minutes from drug administration ]Primary endpoint is defined as the mean difference from baseline of pain scores at 60min.
- Number of reported adverse side-effects [ Time Frame: 30, 90, and 120 minutes from drug administration ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629329
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Kenneth Deitch, DO||Albert Einstein Medical Center|