NCT03938259

Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 52 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 2 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

The sole objective in this study is to evaluate if routine amounts of opioids given for tonsillectomy in children have greater amounts of respiratory depression in children with documented obstructive sleep apnea when compared with patients that do not have obstructive sleep apnea

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 adults 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. It is well known that OSA in children is significantly different from OSA in adults (e.g. gender predilection, central vs. peripheral causation). The manifestation and etiologies are very different in pediatric OSA making it a vastly different disease process.

Conditions

• Respiratory Depression
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Fentanyl	identification of respiratory parameter changes following administration of fentanyl in children with and without OSA

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-08-30
• Completion: 2020-08-30
• First posted: 2019-05-06
• Last updated: 2024-07-26
• Results posted: 2024-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study