Impact Assessment of Positioning on Pain Sensitivity During a Lumbar Puncture in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Pain sensitivity during the lumbar puncture procedure.
研究概览
简要总结
This protocol is a pilot study on standard care. The main goal is to assess the impact of positioning on lumbar puncture process especially on pain sensitivity in children.
It's a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is one year, and number of inclusions forecasted is about 30. Each patient will have one LP in a seated position and one in a lying position.
详细描述
In Pediatric Oncology Hematology, invasive procedures such lumbar punctures or myelograms are essential to diseases diagnosis and treatment.
In hematological malignancies, lumbar punctures are particularly frequent as the therapy processes. Despite a good analgesia, this repeated procedure can generate pain, anxiety, apprehension leading to an increasing difficulty in the procedure realization.
Two positions are possible to carry out lumbar puncture: seated or lying position.
The main goal of this study is to assess the impact of the child positioning during the lumbar puncture process in term of pain, anxiety and stress.
This study is a prospective, monocentric, randomized, open-label, cross-over study. Inclusion period is 1 year, 30 patients will be included from 2 to 18 years old.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 and 18 years old
- •Patients requiring at least 2 therapeutic lumbar punctures
- •Patients able to receive analgesic procedure according to 20005 good practices recommendation
- •Presence of one parent during LP procedure
- •Child able to use assessment scales
- •LP realized with a 20 G needle
- •Platelets > 50000
- •Child with prior clinical examination
- •Affiliated to a health care insurance regimen
排除标准
- •Seated or lying position impossible
- •Lumbar puncture contraindication
- •Patient or parent opposition to second LP realization in the required position
- •Clotting trouble on LP day not allowing the LP procedure
研究组 & 干预措施
LP in a seated position then LP in a lying position
Patients will have first a lumbar puncture (LP) in a seated position then a LP in a lying position
干预措施: LP in a seated position then LP in a lying position (Other)
LP in a lying position then LP in a seated position
Patients will have first a lumbar puncture (LP) in a lying position then a LP in a seated position
干预措施: LP in a lying position then LP in a seated position (Other)
结局指标
主要结局
Pain sensitivity during the lumbar puncture procedure.
时间窗: duration of the procedure
It will be evaluated throw specific pain assessment scales according to patient age
次要结局
- Anxiety during the lumbar puncture procedure on a scale of one to ten(duration of the procedure)
- Time of the lumbar puncture procedure(duration of the procedure)