Opioid-Induced Respiratory DepressionNCT07573150
Pupillometry in Identifying Risk of Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
An observational study of Opioid-Induced Respiratory Depression and Postoperative Complications (Cardiopulmonary), run by NeurOptics Inc at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
- What is being tested?
- Infrared Pupillometry
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 May 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of pediatric patients aged 3 to less than 18 years undergoing tonsillectomy with or without adenoidectomy at participating clinical sites. Participants will be enrolled from routine clinical care settings and will receive standard perioperative management. The study will include patients across a range of clinical characteristics representative of the typical pediatric tonsillectomy population.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Alisha Maslanka, BS, CCRC, 412-491-2748, alisha.maslanka@chp.edu
Himali Vyas, M.B.B.S, 734.203.9987, vyash3@upmc.edu
- Not yet recruiting
UCSF Benioff Children's Hospital
San Francisco, California, 94158
Rachel Eshima McKay, MD, 415-310-7722, Rachel.Eshima@ucsf.edu
Travis Rimando, BS, 415-260-8568, Travis.Rimando@ucsf.edu
About this study
Official title: Pupillometry in Identifying Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
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.
Read more
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.
Read the detailed description
This is a prospective, observational cohort study designed to evaluate the relationship between perioperative pupillary responses and postoperative opioid-induced respiratory depression (OIRD) in pediatric patients undergoing tonsillectomy.
Approximately 300 participants aged 3 to less than 18 years will be enrolled across participating clinical sites. Pupillometry measurements will be obtained using a portable, automated infrared pupillometer at predefined perioperative time points, including preoperative baseline, intraoperative periods, and postoperative recovery. Measurements will include resting pupil diameter, pupillary light reflex parameters (including percent constriction, constriction velocity, dilation velocity, and latency), and pupillary unrest in ambient light.
Pupillometry measurements will be collected solely for research purposes and will not be used to guide clinical management. All patients will receive standard perioperative care as determined by the clinical team.
The primary outcome is the occurrence of postoperative opioid-induced respiratory depression, defined as persistent oxygen desaturation (SpO2 <90%) or respiratory rate <8 breaths per minute in the absence of airway obstruction in the post-anesthesia care unit. Secondary outcomes include opioid consumption, sedation scores, pain scores, and postoperative complications such as nausea and vomiting.
Data will be analyzed to assess the association between pupillary response parameters and the occurrence of respiratory depression, and to support development of predictive models for identifying patients at increased risk of opioid-related adverse events.
- Conditions
- Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
- Being tested
- Infrared Pupillometry
- Keywords
- Sedation, Postoperative Period, Perioperative Monitoring, Pediatrics, Pupillary Light Reflex, Pupillometry, Analgesia, Anesthesia, Opioids, Hypoventilation, Oxygen Desaturation, Opioid-Induced Respiratory Depression, Respiratory Depression
- Medical subject headings
- Postoperative Complications, Agnosia, Hypoventilation, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infrared PupillometryDevice
Also called Quantitative Pupillometry
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Infrared Pupillometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Postoperative Opioid-Induced Respiratory Depression
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.
Measured: From arrival in post-anesthesia care unit (PACU) through PACU discharge (up to 4 hours postoperatively)
Secondary outcomes (4)
Opioid Consumption
Total opioid dose administered during the intraoperative and immediate postoperative period, recorded from the medical record and normalized to body weight where appropriate.
Measured: From induction of anesthesia through transfer to the post-anesthesia care unit (PACU) (up to 2 hours) through PACU discharge (up to 4 hours postoperatively); data collection across these periods may extend up to 6 hours in total.
Sedation Level
Sedation level assessed using clinically documented sedation scales recorded during routine care in the post-anesthesia care unit (PACU), including scales such as the Richmond Agitation-Sedation Scale (RASS; range -5 to +4, where more negative values indicate deeper sedation) or equivalent institution-specific scales. Higher levels of sedation correspond to lower (more negative) scores.
Measured: During PACU stay (up to 4 hours postoperatively)
Pain Scores
Pain intensity scores measured using age-appropriate validated scales (e.g., Numeric Rating Scale or FLACC) as recorded during routine clinical care. The Numeric Rating Scale (0 to 10, where 0 indicates no pain and 10 indicates worst possible pain) and for the Face, Legs, Activity, Cry, Consolability (FLACC) scale (0 to 10, where higher scores indicate greater pain), as recorded during routine clinical care in the post-anesthesia care unit (PACU). Scale selection will be based on patient age and clinical appropriateness.
Measured: During PACU stay (up to 4 hours postoperatively)
Postoperative Nausea and Vomiting
Occurrence of nausea and/or vomiting documented in the medical record during the PACU stay.
Measured: During PACU stay (up to 4 hours postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start4 May 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Induced Respiratory DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NeurOptics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh Medical Center, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Jeffrey W Oliver, PhD, Study director, NeurOptics Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573150
- Sponsor's protocol ID
- NIH-OiRD
- Other IDs
- R44DA055407
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: The study team has not yet determined whether individual participant data will be shared. Any future data sharing will be evaluated following study completion and will consider participant privacy, institutional policies, intellectual property considerations, and applicable NIH and regulatory requirements.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry in Identifying Postoperative Opioid-induced Respiratory Depression in Children Undergoing Tonsillectomy
- ClinicalTrials.gov ID
- NCT07573150
- Acronym / sponsor ID
- NIH-OiRD
- Conditions
- Opioid-Induced Respiratory Depression, Postoperative Complications (Cardiopulmonary), Respiratory Complications Due to Anesthesia
- Keywords
- Sedation, Postoperative Period, Perioperative Monitoring, Pediatrics, Pupillary Light Reflex, Pupillometry, Analgesia, Anesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- NeurOptics IncIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Pittsburgh Medical Center, University of California, San Francisco
- Study start
- 4 May 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, observational cohort study designed to evaluate the relationship between perioperative pupillary responses and postoperative opioid-induced respiratory depression (OIRD) in pediatric patients undergoing tonsillectomy.
Approximately 300 participants aged 3 to less than 18 years will be enrolled across participating clinical sites. Pupillometry measurements will be obtained using a portable, automated infrared pupillometer at predefined perioperative time points, including preoperative baseline, intraoperative periods, and postoperative recovery. Measurements will include resting pupil diameter, pupillary light reflex parameters (including percent constriction, constriction velocity, dilation velocity, and latency), and pupillary unrest in ambient light.
Pupillometry measurements will be collected solely for research purposes and will not be used to guide clinical management. All patients will receive standard perioperative care as determined by the clinical team.
The primary outcome is the occurrence of postoperative opioid-induced respiratory depression, defined as persistent oxygen desaturation (SpO2 <90%) or respiratory rate <8 breaths per minute in the absence of airway obstruction in the post-anesthesia care unit. Secondary outcomes include opioid consumption, sedation scores, pain scores, and postoperative complications such as nausea and vomiting.
Data will be analyzed to assess the association between pupillary response parameters and the occurrence of respiratory depression, and to support development of predictive models for identifying patients at increased risk of opioid-related adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Tonsillectomy Patients | – | Device: Infrared PupillometryPediatric 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of pediatric patients aged 3 to less than 18 years undergoing tonsillectomy with or without adenoidectomy at participating clinical sites. Participants will be enrolled from routine clinical care settings and will receive standard perioperative management. The study will include patients across a range of clinical characteristics representative of the typical pediatric tonsillectomy population.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infrared PupillometryAlso: Quantitative PupillometryNon-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. | Device | Pediatric Tonsillectomy Patients |
Primary outcome
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)
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.
4 secondary outcomes
Opioid Consumption
Time frame: From induction of anesthesia through transfer to the post-anesthesia care unit (PACU) (up to 2 hours) through PACU discharge (up to 4 hours postoperatively); data collection across these periods may extend up to 6 hours in total.
Sedation Level
Time frame: During PACU stay (up to 4 hours postoperatively)
Pain Scores
Time frame: During PACU stay (up to 4 hours postoperatively)
Postoperative Nausea and Vomiting
Time frame: During PACU stay (up to 4 hours postoperatively)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided. The study team has not yet determined whether individual participant data will be shared. Any future data sharing will be evaluated following study completion and will consider participant privacy, institutional policies, intellectual property considerations, and applicable NIH and regulatory requirements.
Related trials for Opioid-Induced Respiratory Depression
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Clinical Evaluation of an Alarm Activated Detection System to Enable Early Intervention of Emerging Respiratory Decline With the Linshom Medical Continuous Predictive Respiratory Sensor (CPRS)
Post Surgical Respiratory Failure, Respiratory Complication
RecruitingObservational study
Timing of Opioid Administration and Postoperative Respiratory Depression.
Respiratory Complications, Opioid Induced Respiratory Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey W Oliver, PhD study director
NeurOptics Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid-Induced Respiratory Depression and Postoperative Complications (Cardiopulmonary), run by NeurOptics Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisha Maslanka, BS, CCRC (412-491-2748, alisha.maslanka@chp.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.