RecruitingNot Applicable

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

United States300 participantsStarted 2026-05-04

Plain-language 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.

Who can participate

Age range

3 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence of Postoperative Opioid-Induced Respiratory Depression

Timeframe: From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)

Trial details

NCT IDNCT07573150

SponsorNeurOptics Inc

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-04-30

Contact for this trial

Alisha Maslanka, BS, CCRC

412-491-2748 alisha.maslanka@chp.edu

View on ClinicalTrials.gov More Opioid-Induced Respiratory Depression trials