Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit.

Study Overview
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Brief Summary
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The ANI monitor is a medical device allowing to measure the response of the autonomic nervous system to a painful stimulus. In the pediatric population under general anesthesia, the ANI score can detect failure of locoregional anesthesia; ANI decreases after painful stimulation during surgery, more markedly with smaller doses of Remifentanil. To date, measurement of ANI in sedated children in pediatric intensive care has not been performed or validated as a method of assessing pain and discomfort.

Official Title
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Assessment of the Validity of the ANI in Children Over 2 Years of Age and Prepubescent Ventilated and Sedated in Pediatric Intensive Care.

Conditions
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Pain, Pediatric ALL

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated Exclusion Criteria: Non sinusal rythm Atropine Pace-macker

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case group<br>children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia Nociception Index (ANI) minimum |  | at 10 minutes before the painful care | 
| ANI minimum |  | at 30 minutes (average lenght of painful care) | 
| ANI minimum |  | at 10 minutes after the painful care | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of ANI minimum between before and after a painful care |  | From 10 minutes before the care to 10 minutes after the care | 
| the correlation between ANI minimum and the COMFORT B behavioral scale. | The COMFORT BEHAVIOURAL (COMFORT-B) SCALE consists of six items: alertness, calmness, respiratory response, body movements, facial tension and muscle tone. Each item goes from 1 to 5, assessing the different intensities. The sum of the six ratings leads to a final score ranging from a minimum of 6 to a maximum of 30. A patient is considered to be under-sedated in case of COMFORT-B scores of 23 or higher, over-sedated in case of COMFORT-B scores of 10 or lower. | From 10 minutes before the care to 10 minutes after the care | 
| the ability of ANI minimum to distingush painful from non painful patient |  | From 10 minutes before the care to 10 minutes after the care | 
| Area under the ROC curve of ANI min calculated over all measurements |  | From 10 minutes before the care to 10 minutes after the care | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive Care Units,, Pain Measurement, ANI, Analgesia Nociception Index, Pediatric,