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

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albert Einstein Healthcare Network
• Treatments: Acetaminophen; Aspirin; Caffeine; Prochlorperazine

Criteria

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.