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Trial record 17 of 263 for:    Migraine AND Acute Migraine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01629329
Recruitment Status : Terminated (no difference found between two groups in a preliminary analysis)
First Posted : June 27, 2012
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):
Kenneth Deitch, Albert Einstein Healthcare Network

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : November 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Mean difference from baseline of VAS pain scores [ Time Frame: 60 minutes from drug administration ]
    Primary endpoint is defined as the mean difference from baseline of pain scores at 60min.

Secondary Outcome Measures :
  1. Number of reported adverse side-effects [ Time Frame: 30, 90, and 120 minutes from drug administration ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01629329

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

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Responsible Party: Kenneth Deitch, Research Director, Dept. of Emergency Medicine, Albert Einstein Healthcare Network Identifier: NCT01629329     History of Changes
Other Study ID Numbers: 4258
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

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

Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants