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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04913038

Acronym

ANI-EP

Enrollment

Registered

2021-06-04

Start date

2021-06-29

Completion date

2023-11-23

Last updated

2025-12-19

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

Conditions

Pain, Pediatric ALL

Keywords

Intensive Care Units,, Pain Measurement, ANI, Analgesia Nociception Index, Pediatric,

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

Inclusion criteria

* Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated

Exclusion criteria

* Non sinusal rythm * Atropine * Pace-macker

Design outcomes

Primary

Measure	Time frame
Analgesia Nociception Index (ANI) minimum	at 10 minutes before the painful care
ANI minimum	at 30 minutes (average lenght of painful care)

Secondary

Measure	Time frame	Description
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.	From 10 minutes before the care to 10 minutes after the care	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.
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	—

Countries

France

Outcome results