Objective Markers of Pain Perception in Pediatric Emergency (TAMALOU)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Suffering, Physical

Treatments: Device: Pupillometry glasses; Device: blood pressure sensors; Device: dermal electrode; Device: electroencephalography helmet; Device: Holter

Study type: Interventional

Funder types: Other

Identifiers

NCT03145454

ANSM (Other Identifier)

1608198

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Pain detection

Experimental group

Description:

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

Treatment:

Device: blood pressure sensors

Device: dermal electrode

Device: Pupillometry glasses

Device: electroencephalography helmet

Device: Holter