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.
2 other identifiers
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 4, 2021
CompletedStudy Start
First participant enrolled
June 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2023
CompletedDecember 19, 2025
November 1, 2023
2.4 years
May 17, 2021
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
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 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
Study Arms (1)
case group
children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care.
Eligibility Criteria
children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care
You may qualify if:
- Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated
You may not qualify if:
- Non sinusal rythm
- Atropine
- Pace-macker
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hop Jeanne de Flandre Chu Lille
Lille, 59037, France
Related Publications (1)
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.
PMID: 40924276DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Morgan RECHER, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2021
First Posted
June 4, 2021
Study Start
June 29, 2021
Primary Completion
November 22, 2023
Study Completion
November 23, 2023
Last Updated
December 19, 2025
Record last verified: 2023-11