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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02364856
• Other study ID #: 2013_22
• Secondary ID: 2014-A00583-44
• Status: Terminated
• Start date: April 24, 2015
• Est. completion date: April 12, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: April 12, 2018
• Est. primary completion date: April 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children
• Pain
• Paralysis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Lille	Clinical Investigation Centre for Innovative Technology Network, Fondation Motrice

Country where clinical trial is conducted

France, 

References & Publications (4)

De Jonckheere J, Rakza T, Logier R, Jeanne M, Jounwaz R, Storme L. Heart rate variability analysis for newborn infants prolonged pain assessment. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:7747-50. doi: 10.1109/IEMBS.2011.6091909. — View 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. — View Citation

Jeanne M, Clément 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ANI at baseline	ANI calculated from Heart rate recordings during 300 seconds in patient's usual position	300 seconds at rest
Secondary	time for recovering	time for recovering baseline ANI after painful stimulation	10 minutes after painful stimulation
Secondary	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
Secondary	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
Secondary	dysautonomic symptoms	results of ANI measures will be compared between two groups according to presence or absence of dysautonomic symptoms	inclusion
Secondary	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