Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea
Key facts
- Who runs it
- Baylor College of Medicine
- Where
- Houston, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Early phase 1
- People taking part
- 90 people enrolled
- Started
- 1 Dec 2021
- Ended
- 1 Nov 2024
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Fentanyl Citrate
- Record updated
- 6 April 2025
Who can take part
- Age
- 2 years to 8 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- Known cardiovascular medications
- Allergy to Fentanyl
- Pulmonary hypertension
- No obstructive sleep apnea
- Central sleep apnea events >5/hour
- IV induction of anesthesia
- Syndromic patients
- Known or suspected difficult airway
- Total intravenous anesthesia required
- Parental refusal
Where in United States
- Texas Childrens HospitalHouston, United States
About the trial
What the trial wants to find out
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity
The 4 groups in the trial
- Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kgExisting treatment, for comparison
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: Fentanyl Citrate
- Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanylExisting treatment, for comparison
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: Fentanyl Citrate
- Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kgExisting treatment, for comparison
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: Fentanyl Citrate
- Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanylExisting treatment, for comparison
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: Fentanyl Citrate
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 6 April 2025