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

Condition(s) studied

Investigational drug(s) / intervention(s)

Infrared Pupillometry: Non-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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Occurrence of Postoperative Opioid-Induced Respiratory Depression — From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)
  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.

Trial sites (2)