Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium, Placebo.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines in the Emergency Department
Overview
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
- Drug Magnesium
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 - Drug Placebo
Prochlorperazine 10 mg administered as an intravenous push over 2 minutes followed by placebo (normal saline)
Primary outcome measures
- Mean change in pain - baseline to 30 minutes [Time frame: Baseline to 30 minutes after initiation of infusion]
Secondary outcome measures (4)
- Mean change in pain - baseline to 45 minutes and baseline to 60 minutes [Time frame: Baseline to 45 minutes and 60 minutes after initiation of infusion]
- Number of adverse events [Time frame: Infusion through hour 2]
- Emergency Department length of stay [Time frame: Hour 24]
- Number of patients that require rescue medications [Time frame: Infusion through hour 2]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Advocate Christ Medical Center Emergency Department — Oak Lawn
Identifiers
NCT: NCT06904287 · IRB00127959