Self-control Trial to Evaluate the Role of Aprepitant in the Prophylaxis of Post-lumbar-punture-headache (PLPH)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- incidence of any grade post-lumbar-puncture headache
研究概览
简要总结
Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.
详细描述
Headache following a lumbar puncture （post-lumbar-puncture headache,PLPH）is a common and often debilitating syndrome, which was reported to occur in about 40% patients who received lumbar puncture. Now there lacks of effective approaches in the prophylaxis of PLPH, although some physicians consider bed rest for at least 6 hours to be a useful methods (Some recent meta-analysis found no benefit of bed rest for any hours in the prevention of PLPH). Studies have found that P substances and its receptor (Neurokinin-1 receptor, NK-1R)have played an important role in the pathogenesis of PLPH. Thus, we hypothesize that use of NK-1R inhibitor (aprepitant) 1 hour before lumbar puncture may decrease the incidence of PLPH and lower the severity of PLPH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed as acute leukemia, or lymphoma
- •Patients will received repeated lumbar puncture (at least 2 times, and at least 2 weeks apart) and intrathecal treatment
- •Without CNS involvement
- •Without headache for at least 1 week before the day of lumbar puncture
- •The platelet count was at least 30×10e9/L
排除标准
- •With CNS involvement of disease
- •With headache before lumbar puncture
- •Needs lumbar puncture more than once a week
研究组 & 干预措施
treatment arm
this treatment arm will received aprepitant 1 hour before lumbar puncture and intrathecal treatment.
干预措施: Aprepitant (Drug)
结局指标
主要结局
incidence of any grade post-lumbar-puncture headache
时间窗: date from the day of lumbar puncture to 2 weeks after lumbar puncture
次要结局
- incidence of grade 3/4 post-lumbar-puncture headache(date from the day of lumbar puncture to 2 weeks after lumbar puncture)
研究者
Liang Wang
Doctor
Sun Yat-sen University