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, and latency in response to light stimulation.
Pupillometry data will be collected for research purposes only and will not be used to guide clinical care or treatment decisions. Standard clinical care will not be altered as part of this study. Clinical outcomes, including the occurrence of postoperative opioid-induced respiratory depression, opioid use, sedation levels, pain scores, and other postoperative events, will be recorded from the medical record.
The goal of this study is to evaluate the relationship between pupillary response patterns and the occurrence of postoperative respiratory depression, and to support the development of predictive models that may improve early identification of patients at risk for opioid-related adverse events.
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
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
NeurOptics Inc
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Pittsburgh Medical Center
Collaborator
University of California, San Francisco
Collaborator