Objective Markers of Pain Perception in Pediatric Emergency (TAMALOU)

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.

Study Overview

• Status: Completed
• Conditions: Suffering, Physical
• Intervention / Treatment: Device: electroencephalography helmet; Device: dermal electrode; Device: blood pressure sensors; Device: Pupillometry glasses; Device: Holter

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • Centre Hospitalier Universitaire de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pain detection; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of alpha spectral power	Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.	During the surgical gesture

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of spectral power low and high frequency	Rate of spectral power low and high frequency according to heart frequency variability result.	During the surgical gesture
Amplitude of the dermal responsiveness	Compare amplitude of the dermal responsiveness according to dermal electrode result.	During the surgical gesture
Amplitude of the pupillary diameter	Compare amplitude of the pupillary diameter according to pupillometry glasses result.	During the surgical gesture

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Study Chair: Florian CHOUCHOU, PhD, Saint-Etienne University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2017
• Primary Completion (Actual): July 17, 2018
• Study Completion (Actual): July 17, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 21, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pain; children; emergency; heart rate; pupillary diameter; electroencephalography; skin conductance
• Additional Relevant MeSH Terms: Pathologic Processes; Neurologic Manifestations; Disease Attributes; Emergencies; Pain
• Other Study ID Numbers: 1608198; ANSM (Other Identifier: 2025-A01697-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No