NCT01629329

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

A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Albert Einstein Healthcare Network · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Migraine Headaches

Interventions

Type	Name	Description
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)
DRUG	Prochlorperazine 10mg	One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-04-01
• Completion: 2014-07-01
• First posted: 2012-06-27
• Last updated: 2020-03-18
• Results posted: 2020-03-18

Locations

1 site across 1 country: United States