Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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The sole objective in this study is to evaluate if routine amounts of opioids given for tonsillectomy in children have greater amounts of respiratory depression in children with documented obstructive sleep apnea when compared with patients that do not have obstructive sleep apnea

Detailed Description
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Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in adults suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. It is well known that OSA in children is significantly different from OSA in adults (e.g. gender predilection, central vs. peripheral causation). The manifestation and etiologies are very different in pediatric OSA making it a vastly different disease process.

Official Title
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Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Conditions
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Respiratory Depression, Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: tonsillectomy or adenotonsillectomy Ages 2 to 8 years Polysomnography with AHI >6 (study group) Polysomnography with AHI =0 or negative OSA 18 questionnaire (control group) Exclusion Criteria: Ages >8 years Patients requiring pre-medication Parental refusal Opioid allergy/intolerance Patients requiring propofol for intubation Patients with known or suspected difficult airway Obesity with body mass index exceeding 30- (control group only) Known cardiovascular disorders Known pulmonary disorders aside from asthma Patients with chronic oxygen requirement History of Prematurity <35 weeks of gestation No recent URI Personal of family history of malignant hyperthermia

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group; patients without obstructive sleep apnea<br>Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes | Drug: Fentanyl<br>* identification of respiratory parameter changes following administration of fentanyl in children with and without OSA<br>* Other names: respiratory changes, CO2, RR, TV;|
| Patients with known obstructive sleep apnea<br>Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes | Drug: Fentanyl<br>* identification of respiratory parameter changes following administration of fentanyl in children with and without OSA<br>* Other names: respiratory changes, CO2, RR, TV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory depression following opioids | Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration | respiratory rate measured 10 minutes following opioid administration | 
| Respiratory depression following opioids | Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration | tidal volume measured 10 minutes following opioid administration | 
| Respiratory depression following opioids | Identification of respiratory depression following fentanyl administration by recording the end-tidal co2 prior to and 10 minutes following fentanyl administration | end tidal co2 measured 10 minutes following opioid administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatrics, opioids, obstructive sleep apnea