A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Mean Difference From Baseline of VAS Pain Scores
研究概览
简要总结
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.
详细描述
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.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Aspirin, Acetaminophen, Caffeine pills (Drug)
Prochlorperazine 10mg
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
干预措施: Prochlorperazine 10mg (Drug)
结局指标
主要结局
Mean Difference From Baseline of VAS Pain Scores
时间窗: 60 minutes from drug administration
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
次要结局
- Number of Reported Adverse Side-effects(30, 90, and 120 minutes from drug administration)