NCT03938259

Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Completed Results posted Last updated 26 July 2024

What this trial tests

trial testing Fentanyl in Respiratory Depression in 52 participants. Completed in 30 August 2020.

Timeline

1 July 2019

Primary endpoint
30 August 2020

30 August 2020

Quick facts

Lead sponsor	Baylor College of Medicine
Status	Completed
Study type	OBSERVATIONAL
Enrollment	52
Start date	1 July 2019
Primary completion	30 August 2020
Estimated completion	30 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Fentanyl (fentanyl) — full drug profile →

Conditions studied

• Respiratory Depression — all drugs for Respiratory Depression →
• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Baylor College of Medicine

Who can join

Adults 2 to 8, any sex, with Respiratory Depression or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Respiratory Depression Following Opioids Primary · Mean respiratory rate % change from baseline measured 10 minutes following opioid administration

Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration

Group	Value	95% CI
Control Group; Patients Without Obstructive Sleep Apnea	-38.1	-42.3 – -33.9
Patients With Known Obstructive Sleep Apnea	-37.1	-43.4 – -30.8

Respiratory Depression Following Opioids Primary · mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration

Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration

Group	Value	95% CI
Control Group; Patients Without Obstructive Sleep Apnea	6.4	-1.2 – 13.9
Patients With Known Obstructive Sleep Apnea	5.4	0.0 – 10.7

Respiratory Depression Following Opioids Primary · mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration

Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration

Group	Value	95% CI
Control Group; Patients Without Obstructive Sleep Apnea	4.0	1.8 – 6.1
Patients With Known Obstructive Sleep Apnea	2.2	0.2 – 4.2

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.