Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine

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.