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Clinical Trials/NCT03145454
NCT03145454
Completed
N/A

Objective Markers of Pain Perception in Pediatric Emergency

Centre Hospitalier Universitaire de Saint Etienne1 site in 1 country22 target enrollmentMay 4, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Suffering, Physical
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
22
Locations
1
Primary Endpoint
Measure of alpha spectral power
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 4, 2017
End Date
July 17, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Outcomes

Primary Outcomes

Measure of alpha spectral power

Time Frame: During the surgical gesture

Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.

Secondary Outcomes

  • Rate of spectral power low and high frequency(During the surgical gesture)
  • Amplitude of the dermal responsiveness(During the surgical gesture)
  • Amplitude of the pupillary diameter(During the surgical gesture)

Study Sites (1)

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