Pain Assessment in Children With Cerebral Palsy Through Parasympathetic Tone Analysis.
NCT ID: NCT02364856
Last Updated: 2019-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
17 participants
OBSERVATIONAL
2015-04-24
2018-04-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Children with cerebral palsy
Analgesia Nociception Index
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.
Interventions
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Analgesia Nociception Index
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* beta-blockers or atropinic treatment
* Pacemaker, cardiac rhythm disease
* Diabetes mellitus
6 Years
18 Years
ALL
No
Sponsors
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Clinical Investigation Centre for Innovative Technology Network
NETWORK
Fondation Motrice
OTHER
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Justine AVEZ-COUTURIER, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2014-A00583-44
Identifier Type: OTHER
Identifier Source: secondary_id
2013_22
Identifier Type: -
Identifier Source: org_study_id
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