Conditions: Migraine Headaches
Keywords: Headache prochlorperazine excedrin migraine treatment efficacy pain scores
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 93
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: 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. arm 2: Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills

Interventions: intervention 1: Aspirin, Acetaminophen, Caffeine pills intervention 2: Prochlorperazine 10mg
Intervention descriptions: intervention 1: 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) intervention 2: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.

Protocol document: