The CHECK Trial: A Comparison of Headache Treatment in the Emergency Department: Compazine Versus Ketamine. A Multi-Center, Randomized, Double-Blind, Clinical Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
Investigators are comparing Ketamine to prochlorperazinecompazine for benign headaches in the ED. Subjects will be randomized into 1 of 2 groups. Group 1 will receive standard treatment of prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV. Group 2 (research arm) will receive Ketamine 0.3 mg/kg along with ondansetron 4 mg IV. Subjects will be seen at 15, 30, 45, and 60 minutes post-intervention to obtain Heart Rate, Blood Pressure, Headache severity, Nausea severity, Vomiting severity, Anxiety severity, and Restlessness severity. At 24-48 hours post intervention we will contact subjects and assess their pain and assess their satisfaction with their migraine pain management as part of this study. Subjects' participation will last up to 48 hours post headache.
详细描述
Screening Visit:
- Obtain signed Informed Consent Document and HIPAA Authorization (research-driven).
- Record: Date of birth, age, phone number, gender, race, ethnicity, social security number, name of standard of care rescue medications (over-the-counter and prescription), current email address (to be used for scheduling only), height (in inches), weight (in pounds), history of traumatic brain injury, concussion, or any mild to severe head trauma, medication use. (research only)
- Review past medical history in Armed Forces Health Longitudinal Technology Application (AHLTA) or ESSENTRIS to verify the inclusion/exclusion criteria.
- Women of childbearing potential will have a serum pregnancy test (5-10 milliliters (mls), approximately 1-2 teaspoons of blood) (research-driven).
Visit 1:
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Heart rate
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Blood pressure
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Headache severity via 100-mm VAS.
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Nausea severity via 100-mm VAS.
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Vomiting severity via 100-mm VAS.
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Anxiety severity via 100-mm VAS.
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Restlessness severity via 100-mm VAS.
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Record type and amount of rescue medications (over-the-counter and prescription) use in the past 7 days. (research only)
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Subjects will be randomized by the pharmacy. We will use a random-number generator and use blocking to ensure roughly equal sample sizes. Both subjects and investigators will be blinded to the study group assignments. Subjects will be randomized by the pharmacy into one of two groups (research-driven):
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Group 1: Standard treatment arm (prochlorperazinecompazine 10 mg IV along with diphenhydramine 25 mg IV)
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Group 2: Research arm (Ketamine 0.3 mg/kg along with ondansetron 4 mg IV)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard treatment arm
compazine 10 mg Intravenously along with diphenhydramine 25 mg Intravenously
干预措施: Compazine (Drug)
Research arm
Ketamine 0.3 mg/kg Intravenously along with ondansetron 4 mg Intravenously
干预措施: Ketamine (Drug)
结局指标
主要结局
Pain Score
时间窗: 15 min, 30 min, 45 min, 60 min
Subjects marked a line on a Visual Analogue Scale rating from None to Severe. Study staff measured the mark in millimeters and converted to a scale from 0 to 100 possible points, with 100 being most severe.
次要结局
未报告次要终点