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

NCT05051189 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: H50267
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity

Conditions

OSA; Opioid; Adenotonsillectomy

Outcome Measures

Primary Outcomes (3)

• 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 at each minute for 10 consecutive 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

  tidal volume measured at each minute for 10 consecutive 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 at each minute for 10 consecutive minutes following opioid administration

Study Arms (4)

Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg

ACTIVE COMPARATOR

Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.

Drug: Fentanyl Citrate

Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanyl

ACTIVE COMPARATOR

Children without OSA having procedures requiring endotracheal intubation and an who will receive opioids (1.0 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes

Drug: Fentanyl Citrate

Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg

ACTIVE COMPARATOR

Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.

Drug: Fentanyl Citrate

Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl

ACTIVE COMPARATOR

Children with OSA having procedures requiring endotracheal intubation and a who will receive opioids (1.5 mcg/kg fentanyl for IBW, max 25 mcg) for evaluation of respiratory changes.

Drug: Fentanyl Citrate

Interventions

Fentanyl Citrate DRUG

Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV

Patients with sleep apnea having oxygen Saturation <85% randomized to 1.0 mcg/kg fentanyl; Patients with sleep apnea having oxygen Saturation <85% randomized to 1.5 mcg/kg fentanyl; Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.0/kg; Patients with sleep apnea having oxygen Saturation >85% randomized to fentanyl 1.5/kg

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• University of Houston: collaborator
• Children's Hospital of Philadelphia: collaborator
• Wake Forest University: collaborator

Study Sites (1)

Texas childrens Hospital

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Adler AC, Chandrakantan A, Nathanson BH, von Ungern-Sternberg BS. An assessment of opioids on respiratory depression in children with and without obstructive sleep apnea. Paediatr Anaesth. 2021 Sep;31(9):977-984. doi: 10.1111/pan.14228. Epub 2021 Jun 16.

  PMID: 34053151 BACKGROUND

• Adler AC, Lin EE, Messner AH, Rosenberg TL, Pecorella S, Keleghan A, Faircloth S, Templeton TW, Harris L, Khan SA, Pednekar GS, Nguyen DT, Chandrakantan A, von Ungern-Sternberg BS. Association of preoperative nocturnal hypoxaemia nadir and fentanyl ventilatory sensitivity in children with obstructive sleep apnoea undergoing general anaesthesia: a multicentre clinical cohort study. Br J Anaesth. 2025 Nov;135(5):1518-1527. doi: 10.1016/j.bja.2025.07.059. Epub 2025 Sep 5.

  PMID: 40914728 DERIVED

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participant will be unaware of the arm
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: 2 groups will be identified- 1. patients with sleep study O2 nadir \>85% 2. patients with sleep study O2 nadir \<85%

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 21, 2021
• Study Start: December 1, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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
• Access Criteria: Written request

Locations

US (1)