Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pain | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- case group
- description
- children over 2 years of age and prepubescent ventilated and sedated in pediatric intensive care.
Primary outcomes (3)
- measure
- Analgesia Nociception Index (ANI) minimum
- timeFrame
- at 10 minutes before the painful care
- measure
- ANI minimum
- timeFrame
- at 30 minutes (average lenght of painful care)
- measure
- ANI minimum
- timeFrame
- at 10 minutes after the painful care
Secondary outcomes (4)
- measure
- Variation of ANI minimum between before and after a painful care
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 12 Years
Show eligibility criteria text
Inclusion Criteria: * Prebubescent chilren (up to 2 years old) Admited in PICU Sedated, ventilated Exclusion Criteria: * Non sinusal rythm * Atropine * Pace-macker
References
Publications (1)
- DERIVEDBarat 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 40924276