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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00487-34 | Other Identifier | ID-RCB number,ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| case group | children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care
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| Name | Affiliation | Role |
|---|---|---|
| Morgan RECHER, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hop Jeanne de Flandre Chu Lille | Lille | 59037 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40924276 | Derived | Barat A, Wojtanowski A, Behal H, Flocteil M, Leteurtre S, De Jonckheere J, Recher M. Evaluation of the Analgesia Nociception Index (ANI) as an indicator of discomfort in deeply sedated, prepubescent patients. J Clin Monit Comput. 2026 Feb;40(1):203-209. doi: 10.1007/s10877-025-01355-2. Epub 2025 Sep 9. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
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| 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 |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |