Pain Clinical Trial
Official title:
Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.
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).
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.
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