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

Study Overview
=================
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.

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.

Conditions
-----------------
Migraine Headaches

Intervention / Treatment
-----------------
* Drug: Aspirin, Acetaminophen, Caffeine pills
* Drug: Prochlorperazine 10mg


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin, Acetaminophen, Caffeine pills<br>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<br>* 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)<br>* Other names: Excedrin;|
| Active Comparator: Prochlorperazine 10mg<br>Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills | Drug: Prochlorperazine 10mg<br>* One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.<br>* 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, prochlorperazine, excedrin migraine, treatment efficacy, pain scores