Clinical trial NCT03145454: Objective Markers of Pain Perception in Pediatric Emergency
Official title: Objective Markers of Pain Perception in Pediatric Emergency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suffering, Physical
Keywords: Pain
children
emergency
electroencephalography
heart rate
skin conductance
pupillary diameter
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Measure of alpha spectral power
timeFrame: During the surgical gesture
Secondary outcomes:
measure: Rate of spectral power low and high frequency
timeFrame: During the surgical gesture
measure: Amplitude of the dermal responsiveness
timeFrame: During the surgical gesture
measure: Amplitude of the pupillary diameter
timeFrame: During the surgical gesture
Other outcomes:
Locations:
city: Saint Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: SAINT-ETIENNE UNIVERSITY
name: Florian CHOUCHOU, PhD
role: STUDY_CHAIR
References: