Objective Markers of Pain Perception in Pediatric Emergency

NCT ID: NCT03145454

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-04
• Study Completion Date: 2018-07-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pain detection

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

Group Type: EXPERIMENTAL

electroencephalography helmet

Intervention Type: DEVICE

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

dermal electrode

Intervention Type: DEVICE

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

blood pressure sensors

Intervention Type: DEVICE

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

Pupillometry glasses

Intervention Type: DEVICE

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

Holter

Intervention Type: DEVICE

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

Interventions

electroencephalography helmet

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

Intervention Type: DEVICE

dermal electrode

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

Intervention Type: DEVICE

blood pressure sensors

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

Intervention Type: DEVICE

Pupillometry glasses

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

Intervention Type: DEVICE

Holter

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hugues PATURAL, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Florian CHOUCHOU, PhD

Role: STUDY_CHAIR

SAINT-ETIENNE UNIVERSITY

Locations

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

1608198

Identifier Type: -

Identifier Source: org_study_id