Evidence map›Paper›PMID 42068463›Full record

Trial reportEuropean journal of pediatrics2026

Pupillometry for pain assessment in noncommunicating children in the pediatric intensive care unit: a prospective accuracy study.

A Portefaix, M Rabilloud, F Baudin, E Dantony, T Ginhoux, B Kassaï-Koupaï, E Javouhey, F Bordet

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in European journal of pediatrics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02847195 (Evaluation of Pupillometry to Assess Analgesia in Children Unable to Communicate Verbally in Pediatric Intensive Care Unit), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02847195 nacompletednot on this map

Evaluation of Pupillometry to Assess Analgesia in Children Unable to Communicate Verbally in Pediatric Intensive Care Unit (PICU)

TypeinterventionalSponsorHospices Civils de LyonRan2014 to 2019Enrolled66ConditionsPediatric Intensive CareArmspupillometry
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

A PortefaixClinical Investigation Center INSERM P-1407, Hospices Civils de Lyon, Lyon, France. aurelie.portefaix@chu-lyon.fr.
M RabilloudLaboratoire de Biométrie et Biologie Evolutive UMR 5558, Université Lyon 1, CNRS, 69100, Villeurbanne, France.
F BaudinService de Reanimation Pédiatrique, Hospices Civils de Lyon, Hopital Femme Mère Enfant, 69500, Bron, France.
E DantonyLaboratoire de Biométrie et Biologie Evolutive UMR 5558, Université Lyon 1, CNRS, 69100, Villeurbanne, France.
T GinhouxClinical Investigation Center INSERM P-1407, Hospices Civils de Lyon, Lyon, France.
B Kassaï-KoupaïClinical Investigation Center INSERM P-1407, Hospices Civils de Lyon, Lyon, France.
E JavouheyService de Reanimation Pédiatrique, Hospices Civils de Lyon, Hopital Femme Mère Enfant, 69500, Bron, France.
F BordetService de Reanimation Pédiatrique, Hospices Civils de Lyon, Hopital Femme Mère Enfant, 69500, Bron, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pain assessment in noncommunicating children in pediatric intensive care unit (PICU) remains a significant clinical challenge, particularly in deeply sedated patients. Pupillometry, a noninvasive objective technique, showed promise in anesthesia settings, but its relevance in PICU is unclear. We assessed feasibility and diagnostic performance of video pupillometry for pain assessment in noncommunicating intubated children in PICU. We conducted a prospective, single-center diagnostic accuracy study in the French PICU of Lyon (France). Children aged 0-18 years under mechanical ventilation and sedation were eligible. Pupillary diameter variation was measured using the AlgiScan® video pupillometer. Pain was defined as a COMFORT-B score > 17, assessed by nurses blinded to pupillometry results. Diagnostic performance was evaluated using the area under the ROC curve (AUC). Specificity was estimated at a sensitivity threshold of 90%. Sixty-six patients were included and 231 individual measurements analyzed; 52 patients (85%) had at least one complete series. The AUC was 73.6% [95% CI 61.1-82.6]. A weak correlation between COMFORT-B scores and pupillary diameter variation (Spearman's ρ = 0.4, p < 0.05) was found. At 90% sensitivity, the threshold was 0.145, with a specificity of 52.2%. Feasibility was limited in neonates under 5 kg and agitated children.

conclusionTo ensure a sensitivity at 90%, the corresponding specificity was quite low and correlation with COMFORT-B was also weak. Feasibility in young infants remains limited due to technical constraints. Further multicenter studies are warranted to clarify its role in analgesia assessment in PICU, as an adjunct to other techniques.

trial registrationClinicalTrials.gov identifier: NCT02847195. WHAT IS KNOWN: •  Pain assessment in noncommunicating children in the pediatric intensive care unit (PICU) remains a major clinical challenge, particularly in sedated or critically ill patients. Additional tools are needed to better assess pain in this population. WHAT IS NEW: •  A weak correlation was found between pupil variation measured by video pupillometry and the COMFORT-B score in PICU patients. Pupillometry may complement existing tools as part of a multimodal approach to pain assessment in this population.

Indexed as

Deep SedationNonverbal CommunicationPain MeasurementPupilRespiration, ArtificialAdolescentChildChild, PreschoolFeasibility StudiesFemaleFranceHumansInfantInfant, NewbornIntensive Care Units, PediatricMaleAnalgesia assessmentCOMFORT-BPediatric intensive care unitPupillometer

Identifiers

PMID42068463
PMCPMC13135524

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.