Objective Markers of Pain Perception in Pediatric Emergency

Study Overview
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Brief Summary
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Pain is a major problem in the care of children in pediatric emergencies. Indeed, its relief rests on the oral communication of the young patient, who does not always able to it (difficult to verbalize, fear of the hospital, problem mental development ...). There is no way in which pain can be apprehended objectively, immediately and effectively. To advance our knowledge of this problem, several approaches have been studied as from functional magnetic resonance imaging (fMRI), electroencephalography (EEG), or from autonomic parameters. However, all these approaches have their limitations: although fMRI presents interesting performances, it allows only a retrospective analysis, and cannot adapt to the clinical context of the young patient for example. EEG-based approaches and autonomic parameters show interesting results but suffer from perfectible sensitivity to muscle activation for EEG whereas the vegetative parameters to stress. In this context, our working hypothesis considers that the search for markers of painful perception must be based on a neurophysiological approach, based on the combined analysis of the EEG and autonomic responses in real time. The aim of this work is to study (1) the cortical (EEG) and autonomic (cardiovascular, skin, pupillary) responses induced by sutures in children who can communicate their pain according to whether they cause pain or not.

Official Title
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Objective Markers of Pain Perception in Pediatric Emergency

Conditions
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Suffering, Physical

Intervention / Treatment
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* Device: electroencephalography helmet
* Device: dermal electrode
* Device: blood pressure sensors
* Device: Pupillometry glasses
* Device: Holter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requiring one or more non-complex sutures in department of pediatric emergency Affiliate or beneficiary of social security (parents) Signature of consent (parents) Exclusion Criteria: Historic of cardiovascular diseases (arterial hypertension, etc), renal or metabolic syndrome (diabetes etc.), psychiatric (depression, etc.) or neurological (epilepsy seizure, etc.) Trouble of heart rhythm Allergy at conductive gel for electrode Sutures requiring a general anesthesia Contraindication at the Xylocaine and/or Paracetamol

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain detection<br>Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter. | Device: electroencephalography helmet<br>* electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.<br>Device: dermal electrode<br>* dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.<br>Device: blood pressure sensors<br>* blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.<br>Device: Pupillometry glasses<br>* Pupillometry glasses will be performed during surgical gesture to determine the pain of child.<br>Device: Holter<br>* Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of alpha spectral power | Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results. | During the surgical gesture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of spectral power low and high frequency | Rate of spectral power low and high frequency according to heart frequency variability result. | During the surgical gesture | 
| Amplitude of the dermal responsiveness | Compare amplitude of the dermal responsiveness according to dermal electrode result. | During the surgical gesture | 
| Amplitude of the pupillary diameter | Compare amplitude of the pupillary diameter according to pupillometry glasses result. | During the surgical gesture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, children, emergency, electroencephalography, heart rate, skin conductance, pupillary diameter