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

Information source: Albert Einstein Healthcare Network
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Headaches

Intervention: Aspirin, Acetaminophen, Caffeine pills (Drug); Prochlorperazine 10mg (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Albert Einstein Healthcare Network

Official(s) and/or principal investigator(s):
Kenneth Deitch, DO, Principal Investigator, Affiliation: Albert Einstein Medical Center


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean difference from baseline of VAS pain scores

Secondary outcome: Number of reported adverse side-effects

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States
Additional Information

Starting date: November 2010
Last updated: June 24, 2014

Page last updated: August 23, 2015

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