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OpenTrials
Completed

NCT Number: NCT03145454

Objective Markers of Pain Perception in Pediatric Emergency

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.

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Key information

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroencephalography helmet

Device

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

dermal electrode

Device

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

blood pressure sensors

Device

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

Pupillometry glasses

Device

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

Holter

Device

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

Primary outcomes

  1. Measure of alpha spectral power

    Time frame: During the surgical gesture

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

Secondary outcomes

  1. Rate of spectral power low and high frequency

    Time frame: During the surgical gesture

    Rate of spectral power low and high frequency according to heart frequency variability result.

  2. Amplitude of the dermal responsiveness

    Time frame: During the surgical gesture

    Compare amplitude of the dermal responsiveness according to dermal electrode result.

  3. Amplitude of the pupillary diameter

    Time frame: During the surgical gesture

    Compare amplitude of the pupillary diameter according to pupillometry glasses result.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: TAMALOU

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 9, 2017
Registry last updated
Oct 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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