Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Migraine Headaches
In brief
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.
Key facts
- Study ID
- NCT01629329
- Run by
- Albert Einstein Healthcare Network
- People needed
- 93
- Starts
- 2010-11-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2020-03-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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