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Objective Markers of Pain Perception in Pediatric Emergency

Objective Markers of Pain Perception in Pediatric Emergency

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03145454
Acronym
TAMALOU
Enrollment
22
Registered
2017-05-09
Start date
2017-05-04
Completion date
2018-07-17
Last updated
2019-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suffering, Physical

Keywords

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

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.

Interventions

DEVICEelectroencephalography helmet

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

DEVICEdermal electrode

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

DEVICEblood pressure sensors

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

DEVICEPupillometry glasses

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

DEVICEHolter

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of alpha spectral powerDuring the surgical gestureCompare measures of alpha spectra power according to electroencephalography helmet and electrode electrocardiography results.

Secondary

MeasureTime frameDescription
Rate of spectral power low and high frequencyDuring the surgical gestureRate of spectral power low and high frequency according to heart frequency variability result.
Amplitude of the dermal responsivenessDuring the surgical gestureCompare amplitude of the dermal responsiveness according to dermal electrode result.
Amplitude of the pupillary diameterDuring the surgical gestureCompare amplitude of the pupillary diameter according to pupillometry glasses result.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026