Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Baylor College of Medicine52 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Depression Obstructive Sleep Apnea

Interventions

FentanylDRUG

identification of respiratory parameter changes following administration of fentanyl in children with and without OSA

Eligibility

Sex: ALLMin age: 2 YearsMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Texas childrens Hospital

Houston, Texas, United States

Outcomes

Primary Outcomes

Respiratory Depression Following Opioids

Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration

Time frame: Mean respiratory rate % change from baseline measured 10 minutes following opioid administration

Respiratory Depression Following Opioids

Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration

Time frame: mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration

Respiratory Depression Following Opioids

Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration

Time frame: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration

Data from ClinicalTrials.gov

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