Evaluating the Effectiveness of Magnesium in Addition to Prochlorperazine for the Treatment of Migraines in the Emergency Department
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mean change in pain - baseline to 30 minutes
研究概览
简要总结
The purpose of this research study is to find out if using magnesium in addition to prochlorperazine will help reduce your migraine pain.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study Drug
Prochlorperazine 10 mg followed by Magnesium 2 g
干预措施: Magnesium (Drug)
Control Arm
Prochlorperazine 10 mg followed by placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in pain - baseline to 30 minutes
时间窗: 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.
次要结局
- Mean change in pain - baseline to 45 minutes and baseline to 60 minutes(Baseline to 45 minutes and 60 minutes after initiation of infusion)
- Number of adverse events(Infusion through hour 2)
- Emergency Department length of stay(Hour 24)
- Number of patients that require rescue medications(Infusion through hour 2)