Clinical trial NCT01629329: Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Migraine Headaches
Keywords: Headache
prochlorperazine
excedrin migraine
treatment efficacy
pain scores
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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.

Primary outcomes:
measure: Mean Difference From Baseline of VAS Pain Scores
timeFrame: 60 minutes from drug administration
Secondary outcomes:
measure: Number of Reported Adverse Side-effects
timeFrame: 30, 90, and 120 minutes from drug administration
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Medical Center
name: Kenneth Deitch, DO
role: PRINCIPAL_INVESTIGATOR
References: