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OpenTrials
Completed

NCT Number: NCT05051189

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

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

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Key information

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Texas childrens Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Citrate

Drug

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 21, 2021
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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