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

Terminated

• Conditions: Cerebral Palsy; Pain; Children
• Interventions: Device: Analgesia Nociception Index

• Registration Number: NCT02364856
• Lead Sponsor: University Hospital, Lille

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-18
• Study Start: 2015-04-24
• Primary Completion: 2018-04-12
• Study Completion: 2018-04-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with cerebral palsy	Analgesia Nociception Index	-

Primary Outcome Measures

Name	Time	Method
Analgesia Nociception Index ANI before and after painful stimulation	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro; 🇫🇷 Lille, France

Centre de Réadaptation Fonctionnelle Marc Sautelet; 🇫🇷 Villeneuve-d'Ascq, France

Hôpital maritime de Zuydcoote, Service de SSR Enfant; 🇫🇷 Zuydcoote, France