CompletedEarly Phase 1

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

United States90 participantsStarted 2021-12-01

Plain-language summary

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

Who can participate

Age range2 Years – 8 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Respiratory depression following opioids

Timeframe: respiratory rate measured at each minute for 10 consecutive minutes following opioid administration

Respiratory depression following opioids

Timeframe: tidal volume measured at each minute for 10 consecutive minutes following opioid administration

Respiratory depression following opioids

Timeframe: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

Trial details

NCT IDNCT05051189

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-01

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