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

Migraine Headaches Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01629329
• Other study ID #: 4258
• Status: Terminated
• Phase: Phase 4
• Start date: November 2010
• Est. completion date: July 2014

Study information

• Verified date: June 2014
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 93
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headaches

Intervention

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)
• Prochlorperazine 10mg
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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