N/A
N=52
Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea
Respiratory Depression · Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT03938259 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Respiratory Depression Following Opioids — -38.1; -37.1 percentage of change from baseline
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Fentanyl (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Depression Following Opioids |
4.0; 2.2 | — |
| PRIMARY Respiratory Depression Following Opioids |
4.0; 2.2 | — |
| PRIMARY Respiratory Depression Following Opioids |
4.0; 2.2 | — |
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
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03938259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.