Postlumbar Puncture Complaints After Lumbar Punctures in Children and Adolescents: Frequency and Impact by Compariosn of Two Needle Designs
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- headache frequency
研究概览
简要总结
The purpose of this study is to compare postlumbar puncture complaints as headache or backache after lumbar puncture with needles with Quincke design or with Sprotte design in children and adolescents.
详细描述
After lumbar puncture patients may develop complaints as position dependent headache, other headache or backache. Several though not all studies in adults showed that the frequency of complaints can be reduced by using non-traumatic Sprotte-design needles instead of cutting Quincke-design needles. In children and adolescents there are no comparable data published. In most pediatric hospitals in Germany Quincke needles are used.
Comparison: Children and adolescents from 4 to 18 years of age who have to undergo a lumbar puncture are randomly attributed to puncture with Quincke needle or with Sprotte needle. During the following days headache (main criterium), position-dependent headache, backache, vomitus, and malaise are noted. Pain is measured with a visual analogue scale/faces scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lumbar puncture necessary for diagnostic reasons
排除标准
- •intrathecal instillation at lumbar puncture
- •patients in whom severity of disease make it impossible to judge endpoint criteria
结局指标
主要结局
headache frequency
headache intensity
次要结局
- position dependent-headache frequency
- position dependent-headache intensity
- backache frequency
- backache intensity
- practicability of needle designs (multiple punctures necessary?, longer lasting?