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

Phase 4

Terminated

• Conditions: Migraine Headaches
• Interventions: Drug: Aspirin, Acetaminophen, Caffeine pills; Drug: Prochlorperazine 10mg

• Registration Number: NCT01629329
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Primary Completion: 2014-04
• Status Verified: 2014-06
• Study Completion: 2014-07
• Results First Submitted: 2020-03-05
• Results First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Results First Posted: 2020-03-18
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 93

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin, Acetaminophen, Caffeine pills	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.
Prochlorperazine 10mg	Prochlorperazine 10mg	Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills

Primary Outcome Measures

Name	Time	Method
Mean Difference From Baseline of VAS Pain Scores	60 minutes from drug administration	0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Secondary Outcome Measures

Name	Time	Method
Number of Reported Adverse Side-effects	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.

Trial Locations

Locations (1)

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States