Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 5
- 主要终点
- Analgesia Nociception Index ANI before and after painful stimulation
研究概览
简要总结
This study evaluates Analgesia Nociception Index (Heart Rate Variability based index) and its variations after painful stimulations in children with cerebral palsy : acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy).
详细描述
Cerebral Palsy (CP) is the most common cause of motor handicap in childhood. CP is caused by damage to the developing brain, resulting in limits in movement, posture, or communication ability. CP affects about one newborn on 450. Pain management is one of the major expectations of CP patients (La Foundation Motrice, 2009) but in this population, pain is not recognized and inadequately treated.
Autonomic nervous system (ANS) is the automatic part of our nervous system regulating vital functions like cardiac beats or respiration. It is divided in sympathetic and parasympathetic. Analysis of heart rate variability (HRV) allows isolation of variations due to parasympathetic and their study. Works from the CIC-IT 807 lead to creation of an index called ANI (Analgesia Nociception Index), which is very sensitive to pain. It is validated on adults (Jeanne, 2012). It could be helpful to assess pain in CP, particularly in patients with communication disabilities. It is important to study this new tool in CP children before developing clinical applications.
Main objective of this study is to demonstrate that ANI is relevant in CP children and that it is sensitive to pain like in adults. Population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres. Duration of the study is 2 years. Parent's consent should be obtained. Investigators will record heart rate of children in 3 conditions in their rehabilitation centres: usual position, acute procedural pain (botulinum toxin injections), and recurrent pain (physiotherapy). Parameters will be calculated in CIC-IT 807 lab (heart rate, ANI). Values of ANI and heart rate before and after painful stimulations will be compared. Correlation between ANI and results of usual pain assessment tools (rFLACC scale, visual analog scale) or characteristics of the population will be analyzed.
Lille University Hospital and CIC-IT 807 lab will collaborate with 2 pediatric rehabilitation centers: Centre Marc Sautelet and Zuydcoote Hospital.
Expected result is that ANI is relevant to CP children. Clinical applications are multiple: pain assessment, adaptation of medical equipment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cerebral Palsy
- •Rehabilitation care with physiotherapy and/or toxinum botulinum injections
- •Absence of identified autonomic nervous system disease
- •Parental and children (if applicable) consent obtained
- •French National Health System cover
排除标准
- •baseline Respiratory Frequency > 30/min
- •beta-blockers or atropinic treatment
- •Pacemaker, cardiac rhythm disease
- •Diabetes mellitus
研究组 & 干预措施
Children with cerebral palsy
干预措施: Analgesia Nociception Index (Device)
结局指标
主要结局
Analgesia Nociception Index ANI before and after painful stimulation
时间窗: 300 seconds before and 300 seconds after painful stimulation
ANI is calculated from heart rate recordings 300 seconds before and after painful stimulations and compared
次要结局
- ANI at baseline(300 seconds at rest)
- time for recovering(10 minutes after painful stimulation)
- pain score measured by Visual Analog Scale(immediately after painful stimulation)
- dysautonomic symptoms(inclusion)
- pain score measured by rFLACC scale(immediately after painful stimulation)
- Gross Motor Function Classification System(inclusion)