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临床试验/NCT03145454
NCT03145454已完成不适用

Objective Markers of Pain Perception in Pediatric Emergency

Centre Hospitalier Universitaire de Saint Etienne2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017年5月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
2
主要终点
Measure of alpha spectral power

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Requiring one or more non-complex sutures in department of pediatric emergency
  • Affiliate or beneficiary of social security (parents)
  • Signature of consent (parents)

排除标准

  • 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

研究组 & 干预措施

Pain detection

Experimental

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

干预措施: electroencephalography helmet (Device)

Pain detection

Experimental

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

干预措施: dermal electrode (Device)

Pain detection

Experimental

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

干预措施: blood pressure sensors (Device)

Pain detection

Experimental

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

干预措施: Pupillometry glasses (Device)

Pain detection

Experimental

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

干预措施: Holter (Device)

结局指标

主要结局

Measure of alpha spectral power

时间窗: During the surgical gesture

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

次要结局

  • Rate of spectral power low and high frequency(During the surgical gesture)
  • Amplitude of the dermal responsiveness(During the surgical gesture)
  • Amplitude of the pupillary diameter(During the surgical gesture)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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