Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03938259
• Other study ID #: H-45486
• Status: Completed
• Start date: July 1, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: March 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Respiratory Depression
• Respiratory Insufficiency
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Fentanyl
identification of respiratory parameter changes following administration of fentanyl in children with and without OSA

Locations

Country	Name	City	State
United States	Texas childrens Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory depression following opioids	identification of ethnicity as a factor related to opioid induced respiratory depression	measured 10 minutes following opioid administration
Other	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
Primary	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
Primary	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
Primary	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