Clinical trial NCT02364856: Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.
Official title: Assessment of Pain Through Parasympathetic Tone Analysis : Applicability in Children With Cerebral Palsy.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cerebral Palsy
Pain
Children
Keywords: Autonomic Nervous System
Cerebral Palsy
Pain
Children
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Clinical Investigation Centre for Innovative Technology Network
name: Fondation Motrice
First posted: 2015-02-18
Enrollment: 17
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our population will be 40 CP children (6-18y) receiving rehabilitation therapy in specialized centres.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Analgesia Nociception Index ANI before and after painful stimulation
timeFrame: 300 seconds before and 300 seconds after painful stimulation
Secondary outcomes:
measure: ANI at baseline
timeFrame: 300 seconds at rest
measure: time for recovering
timeFrame: 10 minutes after painful stimulation
measure: pain score measured by Visual Analog Scale
timeFrame: immediately after painful stimulation
measure: pain score measured by rFLACC scale
timeFrame: immediately after painful stimulation
measure: dysautonomic symptoms
timeFrame: inclusion
measure: Gross Motor Function Classification System
timeFrame: inclusion
Other outcomes:
Locations:
city: Lille
country: France
facility: CHRU de Lille, Pôle Enfant, Hôpital Roger Salengro
city: Villeneuve-d'Ascq
country: France
facility: Centre de Réadaptation Fonctionnelle Marc Sautelet
city: Zuydcoote
country: France
facility: Hôpital maritime de Zuydcoote, Service de SSR Enfant
Study officials:
affiliation: University Hospital, Lille
name: Justine AVEZ-COUTURIER, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeanne M, Delecroix M, De Jonckheere J, Keribedj A, Logier R, Tavernier B. Variations of the analgesia nociception index during propofol anesthesia for total knee replacement. Clin J Pain. 2014 Dec;30(12):1084-8. doi: 10.1097/AJP.0000000000000083.
citation: Jeanne M, Clement C, De Jonckheere J, Logier R, Tavernier B. Variations of the analgesia nociception index during general anaesthesia for laparoscopic abdominal surgery. J Clin Monit Comput. 2012 Aug;26(4):289-94. doi: 10.1007/s10877-012-9354-0. Epub 2012 Mar 28.
citation: De Jonckheere J, Rakza T, Logier R, Jeanne M, Jounwaz R, Storme L. Heart rate variability analysis for newborn infants prolonged pain assessment. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7747-50. doi: 10.1109/IEMBS.2011.6091909.
citation: Faye PM, De Jonckheere J, Logier R, Kuissi E, Jeanne M, Rakza T, Storme L. Newborn infant pain assessment using heart rate variability analysis. Clin J Pain. 2010 Nov-Dec;26(9):777-82. doi: 10.1097/ajp.0b013e3181ed1058.