Objective Markers of Pain Perception in Pediatric Emergency

Not Applicable

Completed

• Conditions: Suffering, Physical
• Interventions: Device: electroencephalography helmet; Device: dermal electrode; Device: blood pressure sensors; Device: Pupillometry glasses; Device: Holter

• Registration Number: NCT03145454
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-04
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-08
• Study First Posted: 2017-05-09
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pain detection	Holter	Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.
Pain detection	electroencephalography helmet	Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.
Pain detection	Pupillometry glasses	Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.
Pain detection	dermal electrode	Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.
Pain detection	blood pressure sensors	Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.

Primary Outcome Measures

Name	Time	Method
Measure of alpha spectral power	During the surgical gesture	Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.

Secondary Outcome Measures

Name	Time	Method
Rate of spectral power low and high frequency	During the surgical gesture	Rate of spectral power low and high frequency according to heart frequency variability result.
Amplitude of the dermal responsiveness	During the surgical gesture	Compare amplitude of the dermal responsiveness according to dermal electrode result.
Amplitude of the pupillary diameter	During the surgical gesture	Compare amplitude of the pupillary diameter according to pupillometry glasses result.

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Saint Etienne; 🇫🇷 Saint Etienne, France