Objective Markers of Pain Perception in Pediatric Emergency (TAMALOU)
Primary Purpose
Suffering, Physical
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalography helmet
dermal electrode
blood pressure sensors
Pupillometry glasses
Holter
Sponsored by
About this trial
This is an interventional basic science trial for Suffering, Physical focused on measuring Pain, children, emergency, electroencephalography, heart rate, skin conductance, pupillary diameter
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
Sites / Locations
- Centre Hospitalier Universitaire de Saint Etienne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pain detection
Arm Description
Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.
Outcomes
Primary Outcome Measures
Measure of alpha spectral power
Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.
Secondary Outcome Measures
Rate of spectral power low and high frequency
Rate of spectral power low and high frequency according to heart frequency variability result.
Amplitude of the dermal responsiveness
Compare amplitude of the dermal responsiveness according to dermal electrode result.
Amplitude of the pupillary diameter
Compare amplitude of the pupillary diameter according to pupillometry glasses result.
Full Information
NCT ID
NCT03145454
First Posted
May 5, 2017
Last Updated
October 21, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03145454
Brief Title
Objective Markers of Pain Perception in Pediatric Emergency
Acronym
TAMALOU
Official Title
Objective Markers of Pain Perception in Pediatric Emergency
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
July 17, 2018 (Actual)
Study Completion Date
July 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suffering, Physical
Keywords
Pain, children, emergency, electroencephalography, heart rate, skin conductance, pupillary diameter
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain detection
Arm Type
Experimental
Arm Description
Electroencephalographical responses will be collected during surgical gesture by different intervention: electroencephalography helmet, dermal electrode, blood pressure sensors, pupillometry glasses and Holter.
Intervention Type
Device
Intervention Name(s)
electroencephalography helmet
Intervention Description
electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.
Intervention Type
Device
Intervention Name(s)
dermal electrode
Intervention Description
dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.
Intervention Type
Device
Intervention Name(s)
blood pressure sensors
Intervention Description
blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.
Intervention Type
Device
Intervention Name(s)
Pupillometry glasses
Intervention Description
Pupillometry glasses will be performed during surgical gesture to determine the pain of child.
Intervention Type
Device
Intervention Name(s)
Holter
Intervention Description
Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.
Primary Outcome Measure Information:
Title
Measure of alpha spectral power
Description
Compare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.
Time Frame
During the surgical gesture
Secondary Outcome Measure Information:
Title
Rate of spectral power low and high frequency
Description
Rate of spectral power low and high frequency according to heart frequency variability result.
Time Frame
During the surgical gesture
Title
Amplitude of the dermal responsiveness
Description
Compare amplitude of the dermal responsiveness according to dermal electrode result.
Time Frame
During the surgical gesture
Title
Amplitude of the pupillary diameter
Description
Compare amplitude of the pupillary diameter according to pupillometry glasses result.
Time Frame
During the surgical gesture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugues PATURAL, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Florian CHOUCHOU, PhD
Organizational Affiliation
SAINT-ETIENNE UNIVERSITY
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Objective Markers of Pain Perception in Pediatric Emergency
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