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
| Type | Name | Description |
|---|---|---|
| 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. |
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.