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Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy

Recruitingn/aAges 3 Years - 17 YearsAllNeurOptics Inc
NCT07573150 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This study will evaluate whether quantitative pupillometry measurements can be used to identify children at risk for postoperative opioid-induced respiratory depression (OIRD) following tonsillectomy. Opioid-induced respiratory depression is a serious and potentially life-threatening complication that can occur after surgery, and current monitoring approaches are limited in their ability to predict which patients are at highest risk. In this prospective observational cohort study, approximately 300 pediatric patients undergoing tonsillectomy will undergo non-invasive pupillometry measurements at defined perioperative time points, including preoperative, intraoperative, and postoperative periods. Pupillometry measurements will be collected using a commercially available, FDA-regulated infrared pupillometer. These measurements will include pupil size, constriction and dilation velocities,

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 3 to less than 18 years * Scheduled to undergo tonsillectomy with or without adenoidectomy * Planned postoperative recovery in a monitored clinical setting (e.g., post-anesthesia care unit) * Ability to obtain informed consent from parent or legal guardian and assent from the participant when developmentally appropriate Exclusion Criteria: * Known neurologic or ophthalmologic conditions that may affect pupillary function * Use of medications known to significantly alter pupillary response outside of standard perioperative care * Inability to obtain adequate pupillometry measurements (e.g., due to eye injury or inability to safely perform measurement) * Patients not receiving opioids as part of perioperative care * Any condition that, in the opinion of the investigator, would interfere with study participation or data interpretation
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What it tests

  • Infrared Pupillometry
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Where

2 sites
UCSF Benioff Children's Hospital
San Francisco, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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