Objective Markers of Pain Perception in Pediatric Emergency

NCT03145454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-10-22

No results posted yet for this study

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.

Conditions

  • Suffering, Physical

Interventions

DEVICE

electroencephalography helmet

electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.

DEVICE

dermal electrode

dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.

DEVICE

blood pressure sensors

blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.

DEVICE

Pupillometry glasses

Pupillometry glasses will be performed during surgical gesture to determine the pain of child.

DEVICE

Holter

Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Hugues PATURAL, MD PhD · CHU SAINT-ETIENNE

  • Florian CHOUCHOU, PhD · SAINT-ETIENNE UNIVERSITY

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2018-07-17
Completion
2018-07-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03145454 on ClinicalTrials.gov