Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

NCT ID: NCT03938259

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-08-30

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.

Conditions

Respiratory Depression; Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Fentanyl

Intervention Type: DRUG

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

Patients with known obstructive sleep apnea

Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes

Fentanyl

Intervention Type: DRUG

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

Interventions

Fentanyl

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

Intervention Type: DRUG

Other Intervention Names

respiratory changes, CO2, RR, TV

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Adam Adler MD, MS, FAAP

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

adam adler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas childrens Hospital

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-45486

Identifier Type: -

Identifier Source: org_study_id