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The purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.
The purpose of this prospective, randomized, double-blinded study is to compare the relative efficacy and safety of intravenous magnesium in conjunction with intravenous prochlorperazine in the treatment of migraines. Participants will be patients presenting to the Emergency Department with primary diagnosis of migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug | Experimental | Prochlorperazine 10 mg followed by Magnesium 2 g |
|
| Control Arm | Active Comparator | Prochlorperazine 10 mg followed by placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium | Drug | Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by magnesium 2 g administered as an intravenous bolus over a period of 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in pain - baseline to 30 minutes | Change in pain score 30 minutes after initiation of infusion. Pain score is measured on a 0-11 point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain. | Baseline to 30 minutes after initiation of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in pain - baseline to 45 minutes and baseline to 60 minutes | Change in pain score 45 minutes and 60 minutes after initiation of infusion. Pain score is measured on a 0-11 point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain. | Baseline to 45 minutes and 60 minutes after initiation of infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan McKillip, MD | Contact | 708-684-6230 | ryan.mckillip@aah.org | |
| Marc McDowell, PharmD | Contact | 708-684-1078 | marc.mcdowell@aah.org |
| Name | Affiliation | Role |
|---|---|---|
| Ryan McKillip, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Christ Medical Center Emergency Department | Recruiting | Oak Lawn | Illinois | 60453 | United States |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008274 | Magnesium |
| ID | Term |
|---|---|
| D008673 | Metals, Alkaline Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
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| Placebo | Drug | Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by placebo (normal saline) |
|
| Number of adverse events |
Number of adverse events related to study drug within first 2 hours of study drug infusion. Adverse events include hypotension, flushing, akathisia, dystonia, nausea/vomiting, dizziness, drowsiness. |
| Infusion through hour 2 |
| Emergency Department length of stay | Total time spent in emergency department up until discharge | Hour 24 |
| Number of patients that require rescue medications | Number of patients that require administration of rescue meds, which include acetaminophen, NSAIDs, or additional antidopaminergic agents, given within first 2 hours after infusion. | Infusion through hour 2 |
| D009422 | Nervous System Diseases |
| D008670 |
| Metals |