Pupillometry to find children at risk for opioid-related breathing problems after tonsillectomy
Pupillometry in Identifying Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
This project will try to see if a quick, noninvasive pupillometry test can identify children having tonsillectomy who are likely to have opioid-related breathing problems after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 3 Years to 17 Years |
| Sex | All |
| Sponsor | NeurOptics Inc Industry-sponsored |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT07573150 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational cohort of about 300 children aged 3 to under 18 undergoing tonsillectomy at participating centers. Automated infrared pupillometry measurements (resting pupil size, percent constriction, constriction and dilation velocities, latency, and pupillary unrest) will be taken at predefined preoperative, intraoperative, and postoperative time points using an FDA-regulated device. Pupillometry data will be collected for research purposes only and will not influence clinical care, while all patients receive standard perioperative management. The primary outcome is postoperative opioid-induced respiratory depression defined by persistent SpO2 <90% or respiratory rate <8 breaths per minute without airway obstruction, and secondary outcomes include opioid consumption, sedation and pain scores, and other postoperative complications.
Who should consider this trial
Good fit: Children aged 3 to under 18 scheduled for tonsillectomy (with or without adenoidectomy) who will recover in a monitored postoperative setting and whose parent or guardian can provide consent (with assent when appropriate).
Not a fit: Children with neurologic or ophthalmologic conditions affecting pupillary function, those not receiving perioperative opioids, or those unable to tolerate reliable pupillometry measurements are unlikely to benefit from the test.
Why it matters
Potential benefit: If successful, this approach could provide a simple, noninvasive bedside test to identify children at higher risk for opioid-induced respiratory depression so clinicians can individualize monitoring and pain management.
How similar studies have performed: Quantitative pupillometry has shown promise in adult and perioperative research for tracking opioid effects, but its use specifically to predict pediatric postoperative opioid-induced respiratory depression after tonsillectomy is novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Francisco, California and 1 other locations
- UCSF Benioff Children's Hospital — San Francisco, California, United States (Not_yet_recruiting)
- UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Alisha Maslanka, BS, CCRC
- Email: alisha.maslanka@chp.edu
- Phone: 412-491-2748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.