Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

April 18, 2024 updated by: Adam Adler MD, MS, FAAP, Baylor College of Medicine
Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 children 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. However, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. The aim of this study is to identify if children with known OSA experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing tonsillectomy or adenotonsillectomy
  • Ages 2 to up to 8 years
  • Preoperative sleep study demonstrating obstructive sleep apnea
  • Intubation without medication (e.g. no propofol prior to intubation)
  • Requirement for airway instrumentation: LMA or ETT
  • Inhalation induction of anesthesia

Exclusion Criteria:

  • No obstructive sleep apnea
  • Central sleep apnea events >5/hour
  • IV induction of anesthesia
  • Syndromic patients
  • Known or suspected difficult airway
  • Allergy to Fentanyl
  • Known cardiovascular medications
  • Pulmonary hypertension
  • Total intravenous anesthesia required
  • Parental refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients with sleep apnea having oxygen Saturation >85%
Children with OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Drug: Fentanyl Citrate
Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV
Active Comparator: Patients with sleep apnea having oxygen Saturation <85%
Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids for evaluation of respiratory changes
Drug: Fentanyl Citrate
Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory depression following opioids
Time Frame: respiratory rate measured at each minute for 10 consecutive minutes following opioid administration
Identification of respiratory depression following fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration
respiratory rate measured at each minute for 10 consecutive minutes following opioid administration
Respiratory depression following opioids
Time Frame: tidal volume measured at each minute for 10 consecutive minutes following opioid administration
Identification of respiratory depression following fentanyl administration by recording the tidal volume prior to and 10 minutes following fentanyl administration
tidal volume measured at each minute for 10 consecutive minutes following opioid administration
Respiratory depression following opioids
Time Frame: end tidal co2 measured at each minute for 10 consecutive minutes following opioid administration
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 at each minute for 10 consecutive minutes following opioid administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Children's Hospital of Philadelphia
University of Houston
Wake Forest University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 21, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H50267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available at the conclusion of the study upon reasonable written request to the PI

IPD Sharing Time Frame

De-identified raw data will be available upon study completion following written request to the PI. There will be no time restriction on data

IPD Sharing Access Criteria

Written request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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