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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01600-45 | Other Identifier | ID-RCB |
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Assess the depth of sedation and analgesia in pediatric intensive care is critical to the management of intubated patients under mechanical ventilation. The responsiveness of the pupil is changed by the sedation and analgesia. Measuring the pupil diameter is proposed in anesthesia and intensive care to assess the quality of analgesia in adult population. Visually measuring the diameter of the pupil remains very imprecise, but this measure can be accurately and quickly performed thanks to portable devices called Pupillometers. Some devices including Algiscan® device (IdMed ) can measure in addition to the pupil diameter, the variation of pupil diameter, the latency of the pupillary reflex and the maximum speed of contraction. Pupillometry was tested in adult ICU patients, during painful and painless procedures [1]. In this study, pupillometry was more sensitive for detecting pain compared to the change in heart rate or bispectral index. The objective of this work is to perform measurements of pupil diameter during painful procedures (e.g. tracheal aspiration) in PICU. In parallel we will continue using the Comfort B-scale (has been validated for assessment of pain in children admitted to a pediatric intensive care unit [2-5] and compare the results of both types of assessment pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pediatric intensive care | Experimental | When aspiration is planned, pain assessment will be performed thrice : 3-5 minutes before aspiration, during aspiration, and 3-5 minutes after aspiration. Pain assessment will be performed with both methods:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pupillometry | Device | This is a safe and painless examination (the device is simply placed on the orbit of the eye). The optical pupillometer is cleaned by doctors before and after each use, using cleaning wipes containing antibacterial, antiviral and antifungal drugs; such wipes are already in use in the service for cleaning equipment. |
| Measure | Description | Time Frame |
|---|---|---|
| pupillary diameter | Estimate the performances of the variation of the pupillary diameter to assess pain in children admitted in PICU in comparison to results from the COMFORT-B scale taken as reference. Pupillometry is assessed using a specific device the Neurolight™ (ID MED™, France), (diagnostic test under evaluation), and compared to pain assessment using the score Comfort B scale ( hetero score assessment of pain in children sedated routinely used in PICU to evaluate pain). | Day 1 |
| Comfort B Score | Estimate the performances of the variation of the pupillary diameter to assess pain in children admitted in PICU in comparison to results from the COMFORT-B scale taken as reference. Pupillometry is assessed using a specific device the Neurolight™ (ID MED™, France), (diagnostic test under evaluation), and compared to pain assessment using the score Comfort B scale ( hetero score assessment of pain in children sedated routinely used in PICU to evaluate pain). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Latency time | Latency time assessed by the video pupillometer | Day 1 |
| pupil diameter variation | Pupil diameter variation assessed by the video pupillometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne BORDET, MD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel | Bron | 69500 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42068463 | Derived | Portefaix A, Rabilloud M, Baudin F, Dantony E, Ginhoux T, Kassai-Koupai B, Javouhey E, Bordet F. Pupillometry for pain assessment in noncommunicating children in the pediatric intensive care unit: a prospective accuracy study. Eur J Pediatr. 2026 May 2;185(5):334. doi: 10.1007/s00431-026-07004-3. |
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| Day 1 |
| diameter variation time | Diameter variation time assessed by the video pupillometer | Day 1 |