A Randomized Placebo-Controlled Trial of Sub-Dissociative Ketamine for Treatment of Acute Migraine-Type Headache in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Achievement of Pain Response After Ketamine Dose.
研究概览
简要总结
This research study will be a prospective, randomized, double-blind, placebo-controlled trial. Because ketamine has yet to be directly studied as treatment for acute migraine headache in the emergency department, the research team is initially interested if ketamine can reduce pain scores in headache patients and reduce the incidence of recurrence while exhibiting an adequate safety profile. By using a placebo-controlled study design, the research team can adequately investigate the effectiveness of the medication in a subgroup previously not well studied.
详细描述
The investigators propose enrollment of patients upon or shortly after presentation to the emergency department for treatment with ketamine or placebo. 30 minutes after study drug is administered, patients will have the option to request rescue medication which will be ordered by the treating physician according to standard emergency department protocol. Pain scores will be documented using the Numerical rating scale (NRS-11), 4-Point Pain Intensity Categorical Scale, and 4-Point Functional Disability Scale at 0 minutes, 30 minutes, and 60 minutes post treatment. Follow-up telephone calls will be made 72-120 hours after treatment to assess the incidence of recurrence of head pain and patient satisfaction with the treatment.
Subjects eligible for this study must present to the emergency department with a chief complaint of primary headache that is determined non-emergent by the treating physician.
Upon block randomization, each subject will receive an intravenous dose of 0.2 mg/kg, with a maximum dose of 30mg, of ketamine or an equivalent volume of saline. After 30 minutes patients will be asked if they need rescue medication, and the treating physician will administer rescue treatment, if requested.
The research hypotheses include:
- The proportion of patients achieving significant pain reduction at 30 minutes will be higher in the ketamine treatment group compared to the placebo group.
- The proportion of patients experiencing pain response, defined as <50% reduction in the visual analog score compare to the baseline and a reduction of the 4-Point Pain Intensity Categorical Scale to a 1 or 0, will be higher for patients receiving ketamine compared to those receiving the placebo.
- Patients treated with ketamine for headache will experience lower recurrence rates within 24 hours
- Ketamine will demonstrate an adequate safety profile.
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
- 是
入选标准
- •18-65 years of age
- •Chief complaint of headache
- •International Classification of Headache Disorder classification of migraine or probable migraine with or without aura
- •Has decision making capacity
- •Provider determination of non-emergent cause
排除标准
- •Over the age of 50 with first time headache
- •Known adverse reaction or tolerance to study medication
- •Headache due to trauma
- •New onset, focal, abnormal, neurologic findings
- •New onset seizures
- •History of metastatic cancer or neoplasm
- •Active psychotic symptoms
- •Altered mental status
- •Provider intends to preform lumbar puncture
- •Pregnancy
- •Breast feeding
- •Previous enrollment in study
- •Fever > 100.3 F
- •Physiologic instability (blood pressure < 90/50 or >170/100, heart rate <50 or >120, chronic respiratory, renal or hepatic failure)
- •Suspected cardiac pain
研究组 & 干预措施
Placebo Control
Patients will receive an equivalent volume of normal saline intravenously.
干预措施: Normal Saline (Drug)
Ketamine
Patients will receive 0.2mg/kg ketamine intravenously over one minute.
干预措施: Ketamine (Drug)
结局指标
主要结局
Achievement of Pain Response After Ketamine Dose.
时间窗: 30 minutes
NRS (National rating scale) pain score change from baseline following ketamine dose. Minimum score is 0, maximum score is 10, and higher scores mean worse pain.
次要结局
- Categorical Pain Score Change From Baseline(30 minutes)
研究者
Corey Heitz
Director of Undergraduate Medical Education, Department of Emergency Medicine
Carilion Clinic