Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Completed

• Conditions: Respiratory Depression; Obstructive Sleep Apnea
• Interventions: Drug: Fentanyl

• Registration Number: NCT03938259
• Lead Sponsor: Baylor College of Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-27
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-07-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Results First Submitted: 2022-02-24
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Results First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• tonsillectomy or adenotonsillectomy
• Ages 2 to 8 years
• Polysomnography with AHI >6 (study group)
• Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group)

Exclusion Criteria

• Ages >8 years
• Patients requiring pre-medication
• Parental refusal
• Opioid allergy/intolerance
• Patients requiring propofol for intubation
• Patients with known or suspected difficult airway
• Obesity with body mass index exceeding 30- (control group only)
• Known cardiovascular disorders
• Known pulmonary disorders aside from asthma
• Patients with chronic oxygen requirement
• History of Prematurity <35 weeks of gestation
• No recent URI
• Personal of family history of malignant hyperthermia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group; patients without obstructive sleep apnea	Fentanyl	Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Patients with known obstructive sleep apnea	Fentanyl	Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes

Primary Outcome Measures

Name	Time	Method
Respiratory Depression Following Opioids	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

Trial Locations

Locations (1)

Texas childrens Hospital; 🇺🇸 Houston, Texas, United States