NCT00809627撤回不适用
A Prospective Trial of IV Caffeine vs Placebo for Post-Dural-Puncture Headache in the Emergency Department
United States Naval Medical Center, Portsmouth1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2007年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pain as measured by Visual Analog Scale
研究概览
简要总结
Caffeine will be studied against placebo in patients with positional headache after a lumbar puncture (aka "spinal headache").
详细描述
Pain will be assessed at set intervals using a Visual Analog Scale. Blood patch therapy will be offered to all those still in pain at the end of one hour after drug administration.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with post dural puncture headache
排除标准
- •age < 18
- •allergic to caffeine
- •cardiac or peripheral vascular disease
- •uncontrolled hypertension
研究组 & 干预措施
1
Experimental
IV caffeine with saline and opiate
干预措施: Caffeine (Drug)
2
Placebo Comparator
IV saline with opiate
干预措施: saline (Drug)
结局指标
主要结局
Pain as measured by Visual Analog Scale
时间窗: 60 minutes
次要结局
未报告次要终点
研究者
研究点 (1)
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