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

March 5, 2020 updated by: Albert Einstein Healthcare Network

A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Compazine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Reported Adverse Side-effects
Time Frame: 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.
30, 90, and 120 minutes from drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein Healthcare Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

April 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

June 25, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 27, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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