Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
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.
Inclusion Criteria:

 -  18 years or older

 -  Headache must meet the IHS criteria for migraine or probable migraine

 -  2 out of 4 of following:

 -  Unilateral location

 -  Throbbing (pulsating) quality

 -  Moderate to severe intensity (inhibits/prohibits daily activities)

 -  Exacerbation with moderate activity or mild activity

 -  During HA, at least 1 out of 3 of following:

 -  Nausea and/or vomiting

 -  Photophobia

 -  Phonophobia

 Exclusion Criteria:

 -  Known allergy to study medications

 -  Pregnancy

 -  < 18 years old

 -  Inability to provide written, informed consent

 -  Patients with positive lumbar puncture or positive CT scan for suspected secondary
 headache

 -  History of peptic ulcer disease

 -  History of liver failure

 -  History of coagulopathy

 -  Gastrointestinal bleeding within the last 3 months

 -  Previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications

 -  Ingestion of other pain medications within the previous six hours deemed to put the
 patient at risk of exceeding a toxic dose of ASA or acetaminophen (> 100mg/kg for ASA
 or acetaminophen)

 -  Vomiting within one hour of receiving oral study medications.