Opioids for Obstructive Sleep Apnea in Children

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Baylor College of Medicine

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I was intubated without receiving any sedatives like propofol.

I will be put to sleep for surgery using inhaled anesthesia.

I require an LMA or ETT for airway management.

See 3 more

Exclusion Criteria

I have high blood pressure in the lungs.

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

My parents have refused participation.

See 7 more

Treatment Details

Interventions

Fentanyl Citrate (Opioid Analgesic)

Trial OverviewThe 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.

Participant Groups

4Treatment groups

Active Control

Group I: Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kgActive Control1 Intervention

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.

Group II: Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanylActive Control1 Intervention

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

Group III: Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kgActive Control1 Intervention

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.

Group IV: Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanylActive Control1 Intervention

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.

Fentanyl Citrate is already approved in Canada for the following indications: