Clinical trial NCT03938259: Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Official title: Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Depression
Obstructive Sleep Apnea
Keywords: pediatrics
opioids
obstructive sleep apnea
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 52
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are assessing the effect of fentanyl on children with and without OSA based on the OSA 18 questionnaire and PSG resepctively. Children must be otherwise healthy as stated above in the eligibility criteria

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Respiratory Depression Following Opioids
timeFrame: Mean respiratory rate % change from baseline measured 10 minutes following opioid administration
measure: Respiratory Depression Following Opioids
timeFrame: mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration
measure: Respiratory Depression Following Opioids
timeFrame: mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas childrens Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: adam adler, MD
role: PRINCIPAL_INVESTIGATOR
References: