Validation of the ANI in Perpubescent Patients in Pediatric Intensive Care Unit. (ANI-EP)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Pediatric ALL

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non sinusal rythm
• Atropine
• Pace-macker

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
case group; children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care.

What is the study measuring?

Primary Outcome Measures

Outcome 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)
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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Morgan RECHER, MD, University Hospital, Lille

Publications and helpful links

General Publications

• 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. 2025 Sep 9. doi: 10.1007/s10877-025-01355-2. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2021
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 23, 2023

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pain Measurement; Pediatric,; Intensive Care Units,; ANI, Analgesia Nociception Index
• Additional Relevant MeSH Terms: Neurologic Manifestations; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hemic and Lymphatic Diseases; Pain; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 2020_92; 2021-A00487-34 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No