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Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT03938259
Recruitment Status : Completed
First Posted : May 6, 2019
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Adam Adler MD, MS, FAAP, Baylor College of Medicine

Study Description
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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

Condition or disease Intervention/treatment
Respiratory Depression Obstructive Sleep Apnea Drug: Fentanyl

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.
Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Actual Study Start Date : July 1, 2019
Actual Primary Completion Date : August 30, 2020
Actual Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Drug: Fentanyl
identification of respiratory parameter changes following administration of fentanyl in children with and without OSA
Other Name: respiratory changes, CO2, RR, TV
Patients with known obstructive sleep apnea
Children with OSA having adenotonsillectomy for obstructive apnea will receive opioids with evaluation of respiratory changes
 Drug: Fentanyl
identification of respiratory parameter changes following administration of fentanyl in children with and without OSA
Other Name: respiratory changes, CO2, RR, TV


Outcome Measures
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Primary Outcome Measures :
  1. Respiratory depression following opioids [ Time Frame: respiratory rate measured 10 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 10 minutes following opioid administration ]
    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

  3. Respiratory depression following opioids [ Time Frame: end tidal co2 measured 10 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


Other Outcome Measures:
  1. Respiratory depression following opioids [ Time Frame: measured 10 minutes following opioid administration ]
    identification of ethnicity as a factor related to opioid induced respiratory depression

  2. Respiratory depression following opioids [ Time Frame: measured 10 minutes following opioid administration ]
    identification of preoperative SpO2 nadir (> or < 85%) as a factor related to opioid induced respiratory depression


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We are assessing the effect of fentanyl on children with and without OSA based on the OSA 18 questionnaire and PSG resepctively. Children must be otherwise healthy as stated above in the eligibility criteria
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03938259


Locations
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United States, Texas
Texas childrens Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: adam adler, MD Baylor College of Medicine
More Information
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Responsible Party: Adam Adler MD, MS, FAAP, Assistant Professor of Anesthesiology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03938259    
Other Study ID Numbers: H-45486
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No information about IP will be shared per the IRB

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adam Adler MD, MS, FAAP, Baylor College of Medicine:
pediatrics
opioids
obstructive sleep apnea
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fentanyl
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics