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
The study population will consist of pediatric patients aged 3 to less than 18 years undergoing tonsillectomy with or without adenoidectomy at participating clinical sites. Participants will be enrolled from routine clinical care settings and will receive standard perioperative management. The study will include patients across a range of clinical characteristics representative of the typical pediatric tonsillectomy population.
Cohort
Prospective
Infrared Pupillometry
DeviceNon-invasive pupillometry measurements will be performed using a commercially available, FDA-regulated infrared pupillometer. Measurements will be collected at predefined perioperative time points for research purposes only and will not be used to guide clinical care.
Occurrence of Postoperative Opioid-Induced Respiratory Depression
Postoperative opioid-induced respiratory depression is defined as the occurrence of either (1) oxygen saturation (SpO2) \<90% for a sustained period, or (2) respiratory rate \<8 breaths per minute, in the absence of airway obstruction, during the post-anesthesia care unit stay. Events will be identified from clinical monitoring data and medical record documentation.
Opioid Consumption
Total opioid dose administered during the intraoperative and immediate postoperative period, recorded from the medical record and normalized to body weight where appropriate.
Sedation Level
Sedation level assessed using clinically documented sedation scales recorded during routine care in the post-anesthesia care unit (PACU), including scales such as the Richmond Agitation-Sedation Scale (RASS; range -5 to +4, where more negative values indicate deeper sedation) or equivalent institution-specific scales. Higher levels of sedation correspond to lower (more negative) scores.
Pain Scores
Pain intensity scores measured using age-appropriate validated scales (e.g., Numeric Rating Scale or FLACC) as recorded during routine clinical care. The Numeric Rating Scale (0 to 10, where 0 indicates no pain and 10 indicates worst possible pain) and for the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0 to 10, where higher scores indicate greater pain), as recorded during routine clinical care in the post-anesthesia care unit (PACU). Scale selection will be based on patient age and clinical appropriateness.
Postoperative Nausea and Vomiting
Occurrence of nausea and/or vomiting documented in the medical record during the PACU stay.
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NeurOptics Inc
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
University of Pittsburgh Medical Center
Collaborator
University of California, San Francisco
Collaborator
