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

Baylor College of Medicine

Status and phase: Completed; Early Phase 1

Conditions: Adenotonsillectomy; Opioid; OSA

Treatments: Drug: Fentanyl Citrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05051189

H50267

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing tonsillectomy or adenotonsillectomy
• Ages 2 to up to 8 years
• Preoperative sleep study demonstrating obstructive sleep apnea
• Intubation without medication (e.g. no propofol prior to intubation)
• Requirement for airway instrumentation: LMA or ETT
• Inhalation induction of anesthesia

Exclusion criteria

• No obstructive sleep apnea
• Central sleep apnea events >5/hour
• IV induction of anesthesia
• Syndromic patients
• Known or suspected difficult airway
• Allergy to Fentanyl
• Known cardiovascular medications
• Pulmonary hypertension
• Total intravenous anesthesia required
• Parental refusal

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 4 patient groups

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

Active Comparator group

Description:

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.

Treatment:

Drug: Fentanyl Citrate

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

Active Comparator group

Description:

Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes

Treatment:

Drug: Fentanyl Citrate

Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg

Active Comparator group

Description:

Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.

Treatment:

Drug: Fentanyl Citrate

Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl

Active Comparator group

Description:

Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.

Treatment:

Drug: Fentanyl Citrate