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

Primary Purpose

Migraine Headaches

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aspirin, Acetaminophen, Caffeine pills
Prochlorperazine 10mg
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Headaches focused on measuring Headache, prochlorperazine, excedrin migraine, treatment efficacy, pain scores

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Albert Einstein Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aspirin, Acetaminophen, Caffeine pills

Prochlorperazine 10mg

Arm Description

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.

Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills

Outcomes

Primary Outcome Measures

Mean Difference From Baseline of VAS Pain Scores
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Secondary Outcome Measures

Number of Reported Adverse Side-effects
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.

Full Information

First Posted
June 25, 2012
Last Updated
March 5, 2020
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT01629329
Brief Title
Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
Acronym
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
no difference found between two groups in a preliminary analysis
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headaches
Keywords
Headache, prochlorperazine, excedrin migraine, treatment efficacy, pain scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin, Acetaminophen, Caffeine pills
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Prochlorperazine 10mg
Arm Type
Active Comparator
Arm Description
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
Intervention Type
Drug
Intervention Name(s)
Aspirin, Acetaminophen, Caffeine pills
Other Intervention Name(s)
Excedrin
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Prochlorperazine 10mg
Other Intervention Name(s)
Compazine
Intervention Description
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
Primary Outcome Measure Information:
Title
Mean Difference From Baseline of VAS Pain Scores
Description
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Time Frame
60 minutes from drug administration
Secondary Outcome Measure Information:
Title
Number of Reported Adverse Side-effects
Description
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.
Time Frame
30, 90, and 120 minutes from drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Deitch, DO
Organizational Affiliation
Albert Einstein Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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