Objective Markers of Pain Perception in Pediatric Emergency

NCT03145454 | Completed

• 2 other identifiers: 1608198ANSM
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Suffering, Physical

Keywords

Pain; children; emergency; electroencephalography; heart rate; skin conductance; pupillary diameter

Outcome Measures

Primary Outcomes (1)

• Measure of alpha spectral power

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

  During the surgical gesture

Secondary Outcomes (3)

• 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 Arms (1)

Pain detection

EXPERIMENTAL

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

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

Interventions

electroencephalography helmet DEVICE

electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.

Pain detection

dermal electrode DEVICE

dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.

Pain detection

blood pressure sensors DEVICE

blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.

Pain detection

Pupillometry glasses DEVICE

Pupillometry glasses will be performed during surgical gesture to determine the pain of child.

Pain detection

Holter DEVICE

Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.

Pain detection

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Requiring one or more non-complex sutures in department of pediatric emergency
• Affiliate or beneficiary of social security (parents)
• Signature of consent (parents)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Pain; Emergencies

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Hugues PATURAL, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

• Florian CHOUCHOU, PhD

  SAINT-ETIENNE UNIVERSITY

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 9, 2017
• Study Start: May 4, 2017
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)