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

This study has been terminated.
(no difference found between two groups in a preliminary analysis)
Information provided by (Responsible Party):
Kenneth Deitch, Albert Einstein Healthcare Network Identifier:
First received: June 25, 2012
Last updated: June 24, 2014
Last verified: June 2014
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.

Condition Intervention Phase
Migraine Headaches
Drug: Aspirin, Acetaminophen, Caffeine pills
Drug: Prochlorperazine 10mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.

Resource links provided by NLM:

Further study details as provided by Albert Einstein Healthcare Network:

Primary Outcome Measures:
  • Mean difference from baseline of VAS pain scores [ Time Frame: 60 minutes from drug administration ] [ Designated as safety issue: No ]
    Primary endpoint is defined as the mean difference from baseline of pain scores at 60min.

Secondary Outcome Measures:
  • Number of reported adverse side-effects [ Time Frame: 30, 90, and 120 minutes from drug administration ] [ Designated as safety issue: No ]
    Secondary endpoints will also be assessed at 30min, 90min and 120min. Additional secondary endpoints will be in the number of reported adverse side-effects, defined as muscle spasm, tiredness, extreme restlessness, GI upset, vomiting in the ED and treatment failure rate.

Enrollment: 93
Study Start Date: November 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin, Acetaminophen, Caffeine pills
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.
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)
Other Name: Excedrin
Active Comparator: Prochlorperazine 10mg
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
Drug: Prochlorperazine 10mg
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
Other Name: Compazine

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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01629329

United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Sponsors and Collaborators
Albert Einstein Healthcare Network
Principal Investigator: Kenneth Deitch, DO Albert Einstein Medical Center
  More Information

Responsible Party: Kenneth Deitch, Research Director, Dept. of Emergency Medicine, Albert Einstein Healthcare Network Identifier: NCT01629329     History of Changes
Other Study ID Numbers: 4258 
Study First Received: June 25, 2012
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein Healthcare Network:
excedrin migraine
treatment efficacy
pain scores

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipsychotic Agents
Antirheumatic Agents
Autonomic Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Cyclooxygenase Inhibitors
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents processed this record on May 26, 2016