NCT05051189

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• OSA
• Opioid
• Adenotonsillectomy

Interventions

Type	Name	Description
DRUG	Fentanyl Citrate	Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2021-09-21
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study