service de réanimation pédiatrique, Hôpital Femme Mère Enfant (HFME), Hospices Civils de Lyon, 59 Boulevard Pinel
Bron, 69500, France
NCT Number: NCT02847195
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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Notify MeUp to 18 year
All sexes
Interventional
Not applicable
Bron, 69500, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 1
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).
Time frame: Day 1
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).
Time frame: Day 1
Latency time assessed by the video pupillometer
Time frame: Day 1
Pupil diameter variation assessed by the video pupillometer
Time frame: Day 1
Diameter variation time assessed by the video pupillometer
Hospices Civils de Lyon
Other
Evaluation of Pupillometry to Assess Analgesia in Children Unable to Communicate Verbally in Pediatric Intensive Care Unit (PICU)
Acronym: Pupillomètre
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