Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
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Purpose
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. |
- 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.
- 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.
| Estimated Enrollment: | 140 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | December 2013 (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.
Eligibility| 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| United States, Pennsylvania | |
| Albert Einstein Medical Center | |
| Philadelphia, Pennsylvania, United States, 19141 | |
| Principal Investigator: | Kenneth Deitch, DO | Albert Einstein Medical Center |
More Information
No publications provided
| Responsible Party: | Kenneth Deitch, Research Director, Dept. of Emergency Medicine, Albert Einstein Healthcare Network |
| ClinicalTrials.gov Identifier: | NCT01629329 History of Changes |
| Other Study ID Numbers: | 4258 |
| Study First Received: | June 25, 2012 |
| Last Updated: | February 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Albert Einstein Healthcare Network:
|
Headache prochlorperazine excedrin migraine treatment efficacy pain scores |
Additional relevant MeSH terms:
|
Headache Migraine Disorders Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Acetaminophen Aspirin Caffeine Prochlorperazine Antipyretics |
Physiological Effects of Drugs Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013