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 range

2 Years – 8 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More OSA trials

Who can participate

Age range

2 Years – 8 Years

Sex

ALL

See this in plain English?

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

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