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Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05051189
Enrollment
90
Registered
2021-09-21
Start date
2021-12-01
Completion date
2024-11-01
Last updated
2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillectomy, Opioid, OSA

Brief summary

Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity

Detailed description

Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in children suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. However, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. The aim of this study is to identify if children with known OSA experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.

Interventions

DRUGFentanyl Citrate

Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV

Sponsors

University of Houston
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
Wake Forest University
CollaboratorOTHER
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Masking description

The participant will be unaware of the arm

Intervention model description

2 groups will be identified- 1. patients with sleep study O2 nadir \>85% 2. patients with sleep study O2 nadir \<85%

Eligibility

Sex/Gender
ALL
Age
2 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing tonsillectomy or adenotonsillectomy * Ages 2 to up to 8 years * Preoperative sleep study demonstrating obstructive sleep apnea * Intubation without medication (e.g. no propofol prior to intubation) * Requirement for airway instrumentation: LMA or ETT * Inhalation induction of anesthesia

Exclusion criteria

* No obstructive sleep apnea * Central sleep apnea events \>5/hour * IV induction of anesthesia * Syndromic patients * Known or suspected difficult airway * Allergy to Fentanyl * Known cardiovascular medications * Pulmonary hypertension * Total intravenous anesthesia required * Parental refusal

Design outcomes

Primary

MeasureTime frameDescription
Respiratory depression following opioidsrespiratory rate measured at each minute for 10 consecutive minutes following opioid administrationIdentification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026