Migraine Headaches
Conditions
Keywords
Headache, prochlorperazine, excedrin migraine, treatment efficacy, pain scores
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.
Interventions
DRUGAspirin, 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)
DRUGProchlorperazine 10mg
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
Sponsors
Albert Einstein Healthcare Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference From Baseline of VAS Pain Scores | 60 minutes from drug administration | 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Reported Adverse Side-effects | 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. |
Countries
United States
Participant flow
Recruitment details
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Pre-assignment details
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Participants by arm
| Arm | Count |
|---|---|
| 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.
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) | 0 |
| Prochlorperazine 10mg Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: 60 minutes from drug administration
Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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.
Time frame: 30, 90, and 120 minutes from drug administration
Population: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available