Pupillometry to find children at risk for opioid-related breathing problems after tonsillectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UPMC Children's Hospital of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting
• UCSF Benioff Children's Hospital
  San Francisco, California, United States Not yet recruiting

Study contacts

• Study coordinator: Alisha Maslanka, BS, CCRC
• Email: alisha.maslanka@chp.edu
• Phone: 412-491-2748

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.