Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

NCT03938259 | Completed Results DMC FDA Drug

• 1 other identifier: H-45486
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Depression; Obstructive Sleep Apnea

Keywords

pediatrics; opioids; obstructive sleep apnea

Outcome Measures

Primary Outcomes (3)

• Respiratory Depression Following Opioids

  Identification of respiratory depression following routine fentanyl administration by recording the respiratory rate prior to and 10 minutes following fentanyl administration

  Mean respiratory rate % change from baseline measured 10 minutes following opioid administration

• Respiratory Depression Following Opioids

  Identification of respiratory depression following routine fentanyl administration by recording the tidal volume % change from baseline prior to and 10 minutes following fentanyl administration

  mean percentage of change from baseline in tidal volume measured 10 minutes following opioid administration

• Respiratory Depression Following Opioids

  Identification of respiratory depression following routine fentanyl administration by recording the end-tidal co2 % change from baseline prior to and 10 minutes following fentanyl administration

  mean percentage of change from baseline in end tidal co2 measured 10 minutes following opioid administration

Study Arms (2)

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

Patients with known obstructive sleep apnea

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

Drug: Fentanyl

Interventions

Fentanyl DRUG

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

Also known as: respiratory changes, CO2, RR, TV

Control group; patients without obstructive sleep apnea; Patients with known obstructive sleep apnea

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas childrens Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Sleep Apnea, Obstructive

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Adam Adler
• Organization: Baylor College of Medicine7

Adam.adler@bcm.edu

832-824-5801

Study Officials

• adam adler, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: May 6, 2019
• Study Start: July 1, 2019
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)