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Clinical Trials/NCT02847195
NCT02847195
Completed
Not Applicable

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

Hospices Civils de Lyon1 site in 1 country66 target enrollmentDecember 2, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Intensive Care
Sponsor
Hospices Civils de Lyon
Enrollment
66
Locations
1
Primary Endpoint
pupillary diameter
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2014
End Date
July 2, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • children (age \< 18 years) hospitalized in PICU
  • sedated because they are receiving mechanical ventilation,
  • for whom parents (or their representatives) have given their oral consent after written information.

Exclusion Criteria

  • children receiving curare drugs
  • with congenital or acquired neurological,
  • with ophthalmologic pathology
  • or who does not benefit from social insurance coverage.

Outcomes

Primary Outcomes

pupillary diameter

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).

Comfort B Score

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).

Secondary Outcomes

  • Latency time(Day 1)
  • pupil diameter variation(Day 1)
  • diameter variation time(Day 1)

Study Sites (1)

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