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Pupillometry for Postoperative Opioid-Induced Respiratory Depression Risk in Children

This study is looking at whether a special eye measurement, called pupillometry, can help identify children at risk for breathing problems after tonsil surgery. These breathing problems, called opioid-induced respiratory depression (OIRD), can happen when children are given pain medicine (opioids) after surgery. The study will use a non-invasive device called an infrared pupillometer to measure your child's pupils at different times around their surgery. These measurements are for research only and won't change your child's care. The main goal is to see if these measurements can predict which children might have OIRD, which is defined as low oxygen levels or very slow breathing in the recovery room. Children aged 3 to 17 years who are having a tonsillectomy can participate.

Study design
This is an observational study involving about 300 children. It will look at the relationship between pupil measurements and breathing problems after surgery.
What's involved
Your child will have non-invasive pupillometry measurements taken at different times before, during, and after their tonsillectomy surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of breathing problems will be measured from arrival in the post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively).

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NCT07573150

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

Recruiting
Not specifiedAges 3–17Observational
NeurOptics Inc
~300 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Infrared Pupillometry

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Postoperative Opioid-Induced Respiratory Depression
Measured over From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)

Conditions

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

Explore related trials

Tonsillectomy

Where it's being run

2 sites across 2 states
California1
Pennsylvania1

Study leadership

  • Jeffrey W Oliver, PhD · STUDY_DIRECTOR · NeurOptics Inc

Who to contact

Alisha Maslanka, BS, CCRC
[email protected]
412-491-2748
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Occurrence of Postoperative Opioid-Induced Respiratory DepressionFrom 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.