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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea; Respiratory Depression
• Intervention / Treatment: Drug: Fentanyl

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Childrens Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory depression following opioids	identification of ethnicity as a factor related to opioid induced respiratory depression	measured 10 minutes following opioid administration
Respiratory depression following opioids	identification of preoperative SpO2 nadir (> or < 85%) as a factor related to opioid induced respiratory depression	measured 10 minutes following opioid administration

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: April 27, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (ACTUAL): May 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: pediatrics; obstructive sleep apnea; opioids
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Insufficiency; Apnea; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: H-45486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No information about IP will be shared per the IRB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No