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临床试验/NCT01977001
NCT01977001已完成不适用

Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department

Hennepin Healthcare Research Institute1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
Change from Baseline in Pain Level

研究概览

简要总结

MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of MigraineBoxTM will be studied in primary headaches in the emergency department. The user simply reclines his/her head and neck into this device that has contours that support the head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen insert is placed inside. This will gradually cool the water surrounding the patient's head and theoretically provide headache relief.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-85 years old
  • Benign headache
  • Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic

排除标准

  • Unable to provide informed consent
  • Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection
  • Known renal impairment
  • Known hepatic impairment
  • A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease
  • Perforated ear drum

结局指标

主要结局

Change from Baseline in Pain Level

时间窗: Baseline, 30 minutes, 60 minutes

Patients will be asked to complete a 100 mm visual analog scale and a four point Likert scale concerning their pain.

次要结局

  • Change from Baseline in Nausea(Baseline, 30 minutes, 60 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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