Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

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

Completed

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Key information

Conditions

Respiratory Depression Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas childrens Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

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

Other names: respiratory changes, CO2, RR, TV

Primary outcomes

Respiratory Depression Following Opioids

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: May 6, 2019
Registry last updated: Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed