Migraine
Conditions
Keywords
Migraine, Magnesium
Brief summary
The purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.
Detailed description
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.
Interventions
DRUGMagnesium
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
DRUGPlacebo
Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by placebo (normal saline)
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years or older * Able to provide informed consent * English speaking * Primary diagnosis of migraine. Patient with a previous diagnosis of migraine, who experience headaches with typical migraine features (e.g at least 2-3 of the following: recurrent, unilateral, pounding or throbbing in nature, associated with nausea), AND with a clinical exclusion of migraine mimics
Exclusion criteria
* Pregnancy defined as a positive urine HCG * Allergy or sensitivity to study drug * Stated history of renal insufficiency * Documented history of myasthenia gravis * Consumption of study drug within 48 hours prior to enrollment * Previously enrolled in this trial during a different patient encounter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in pain - baseline to 30 minutes | Baseline to 30 minutes after initiation of infusion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in pain - baseline to 45 minutes and baseline to 60 minutes | Baseline to 45 minutes and 60 minutes after initiation of infusion | 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. |
| Number of adverse events | Infusion through hour 2 | 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. |
| Emergency Department length of stay | Hour 24 | Total time spent in emergency department up until discharge |
| Number of patients that require rescue medications | Infusion through hour 2 | Number of patients that require administration of rescue meds, which include acetaminophen, NSAIDs, or additional antidopaminergic agents, given within first 2 hours after infusion. |
Countries
United States
Contacts
CONTACTRyan McKillip, MD
CONTACTMarc McDowell, PharmD
PRINCIPAL_INVESTIGATORRyan McKillip, MD
Wake Forest University Health Sciences
Outcome results
None listed