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Opioid Analgesic

Opioids for Obstructive Sleep Apnea in Children

Phase < 1

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Intubation without medication (e.g. no propofol prior to intubation)

Requirement for airway instrumentation: LMA or ETT

Must not have

Pulmonary hypertension

Total intravenous anesthesia required

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

Awards & highlights

No Placebo-Only Group

Summary

This trial found that children with OSA have different responses to opioids depending on the degree of their intermittent hypoxemia.

Who is the study for?

This trial is for children aged 2 to 8 with obstructive sleep apnea who are undergoing tonsillectomy or adenotonsillectomy. They must have had a preoperative sleep study confirming the condition and require airway management during surgery. Children with syndromes, central sleep apnea, difficult airways, fentanyl allergy, cardiovascular issues, or pulmonary hypertension cannot participate.

What is being tested?

The trial is studying how Fentanyl Citrate affects breathing control in children with obstructive sleep apnea during surgery. It aims to understand if intermittent low oxygen levels change the way these kids respond to opioids like Fentanyl.

What are the potential side effects?

Fentanyl may cause slowed breathing, changes in blood pressure, nausea, itching or rash at the injection site. In some cases it can lead to excessive sedation or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was intubated without receiving any sedatives like propofol.

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I require an LMA or ETT for airway management.

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I am scheduled for a tonsil or tonsil and adenoid removal surgery.

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I have been diagnosed with obstructive sleep apnea through a sleep study.

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I am between 2 and 8 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have high blood pressure in the lungs.

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I need to be fully asleep with IV anesthesia for my procedure.

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My parents have refused participation.

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I do not have obstructive sleep apnea.

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I will be given anesthesia through an IV.

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I am taking medication for heart conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration for reporting.