Clinical Trials Directory

Trials / Completed

CompletedNCT03145454

Objective Markers of Pain Perception in Pediatric Emergency

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
8 Years – 12 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DEVICEelectroencephalography helmetelectroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.
DEVICEdermal electrodedermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.
DEVICEblood pressure sensorsblood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.
DEVICEPupillometry glassesPupillometry glasses will be performed during surgical gesture to determine the pain of child.
DEVICEHolterThree electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.

Timeline

Start date
2017-05-04
Primary completion
2018-07-17
Completion
2018-07-17
First posted
2017-05-09
Last updated
2019-10-22

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03145454. Inclusion in this directory is not an endorsement.