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

Conditions

• Opioid-Induced Respiratory Depression
• Postoperative Complications (Cardiopulmonary)
• Respiratory Complications Due to Anesthesia

Eligibility Criteria

Sex

ALL

Age

3 Years - 17 Years

Healthy Volunteers

Accepted

Interventions

• Infrared Pupillometry — DEVICE
  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 Details

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.

Key Dates

Start date

May 4, 2026

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: Pediatric Tonsillectomy Patients
  Pediatric participants aged 3 to less than 18 years undergoing tonsillectomy. Participants will undergo non-invasive pupillometry measurements at predefined perioperative time points. Pupillometry data are collected for research purposes only and will not be used to guide clinical care. All participants will receive standard perioperative management as determined by the clinical team.

Primary Outcome Measure

Occurrence of Postoperative Opioid-Induced Respiratory Depression [ Time Frame: From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively) ]

Central Contacts

• Alisha Maslanka, BS, CCRC
  412-491-2748
  [email protected]
• Senthilkumar Sadhasivam, MD
  513-253-4684
  [email protected]

Locations (2)

Find similar trials in San Francisco, CA

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