Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.

Conditions
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Cerebral Palsy, Pain, Children

Intervention / Treatment
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* Device: Analgesia Nociception Index


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: baseline Respiratory Frequency > 30/min beta-blockers or atropinic treatment Pacemaker, cardiac rhythm disease Diabetes mellitus

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children with cerebral palsy<br> | Device: Analgesia Nociception Index<br>* The Analgesia Nociception Index (ANI, MDoloris Medical Systems, Lille, France), based on Heart Rate Variability analysis, measures continuously and non-invasively the influence of Respiratory Sinus Arrhythmia on the heart rate. This 0-100 index indicates the proportion of paraS over sympathetic activity. In adults during surgery under general anesthesia, ANI decreases after painful stimulation and has been related to the balance between analgesia and nociception. ANI is calculated from heart rate recording.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Nociception Index ANI before and after painful stimulation | ANI is calculated from heart rate recordings 300 seconds before and after painful stimulations and compared | 300 seconds before and 300 seconds after painful stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ANI at baseline | ANI calculated from Heart rate recordings during 300 seconds in patient's usual position | 300 seconds at rest | 
| time for recovering | time for recovering baseline ANI after painful stimulation | 10 minutes after painful stimulation | 
| pain score measured by Visual Analog Scale | when VAS will be applicable, children will be asked to score their pain with VAS scale; results of pain ratings with VAS will be compared to ANI results | immediately after painful stimulation | 
| pain score measured by rFLACC scale | rFLACC scale will be scored immediately after painful stimulation; results of pain ratings with rFLACC will be compared to ANI results | immediately after painful stimulation | 
| dysautonomic symptoms | results of ANI measures will be compared between two groups according to presence or absence of dysautonomic symptoms | inclusion | 
| Gross Motor Function Classification System | results of ANI measures will be compared to the severity of motor impairment through the Gross Motor Function Classification System | inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic Nervous System, Cerebral Palsy, Pain, Children