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

NCT ID: NCT01629329

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 93 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-07-31

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.

Conditions

Migraine Headaches

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aspirin, Acetaminophen, Caffeine pills

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Prochlorperazine 10mg

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: DRUG

Prochlorperazine 10mg

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

Intervention Type: DRUG

Other Intervention Names

Excedrin; Compazine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Einstein Healthcare Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenneth Deitch, DO

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein Medical Center

Locations

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

4258

Identifier Type: -

Identifier Source: org_study_id