Randomized Evaluation of a Positioning Pillow for Lumbar Puncture in Paediatric Hematology-Oncology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 4
- 主要终点
- technical quality of the LP, classified as success or failure.
研究概览
简要总结
We have developed a positioning cushion for LP which allows the child to be relaxed in an adequate position, and to maintain this position throughout LP. This study was aimed at evaluating the benefit of the device on the technical quality of LPs, on pain, anxiety, post LP syndrome, and on the satisfaction of children, their parents and caregivers.
The study was a two-centre, open, randomized trial, with two parallel groups. Children aged 2 to 18 years undergoing a LP were eligible, if not included in the study before. Those who had used the cushion before, with a medical reason preventing the use of the cushion, those refusing or whose parents refused could not be included. Randomization was stratified by centre.
Four cushion sizes were available for the age ranges: 2-6 years, 6-10 years, 10-15 and 15-18 years. The primary outcome was the rate of success, defined as a LP reaching its objective at the first attempt, without hemorrhage (visible hemorrhage or RBC > 50/mm3 in the CSF sample). Secondary outcomes included: the child's pain using a visual analogic scale (VAS), parents and caregiver perception of the child's pain (VAS); the children, parents, caregiver and physician performing the LP satisfaction; children cooperation using the "Le Baron Scale", and the occurrence of a post LP syndrome.
详细描述
Our study was an open, randomized, controlled trial, with two parallel groups assigned to "LP pillow" or "no intervention" conducted in patients undergoing LP.
Participants Children aged 2 to 18 years undergoing an LP were eligible for inclusion. Children who had already participated or used the LP pillow, who had a medical condition (orthopaedic anomaly) contraindicating the use of the LP pillow or whose parents refused consent were excluded.
A permuted-block algorithm was used for randomization, with participants stratified according to centre. Concealed allocation was achieved by a phone call to the coordination centre after eligibility check and baseline data collection.
Intervention The LP pillow was made of polyethylene microcellular foam, coated with rubber to facilitate decontamination. It was placed on the thighs of the child sitting with the trunk leaning forward. This position ensures maximum lumbar flexion whereas resting the trunk on the pillow allows relaxation of paravertebral muscles. The axis of the body and the spinal column were maintained perfectly symmetrical in the sagittal plane (see illustration Fig 1).
The pillow included side supports for the head; the face remained uncovered so that the child could breathe and speak comfortably; this also facilitated nitrous oxide administration. Props supporting the patient's arms maintained the cervical column in a neutral position. An opening allowed touching the child's hands and forearms. Splints at the bottom side immobilized the child's thighs to ensure effective stabilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Children aged 2 to 18 years undergoing an LP
排除标准
- •Children who had already participated or used the LP pillow
- •medical condition (orthopaedic anomaly) contraindicating the use of the LP pillow
- •Parents refusal
结局指标
主要结局
technical quality of the LP, classified as success or failure.
时间窗: immediate
次要结局
- number of attending persons(immediate)
- satisfaction of the children, parents, caregivers and physician performing the LP assessed using verbal scoring;(immediate)
- child's pain(immediate)
- symptoms and duration of post-LP syndrome assessed 48 hours after LP(48 hours)