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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-11-01

Brief Summary

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

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Detailed Description

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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

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OSA Opioid Adenotonsillectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups will be identified-

1. patients with sleep study O2 nadir \>85%
2. patients with sleep study O2 nadir \<85%

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

The participant will be unaware of the arm

Study Groups

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Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg

Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.

Group Type ACTIVE_COMPARATOR