N/A Completed N=52

Effect of Opioids on Ventilation in Children With Obstructive Sleep Apnea

Depression · Obstructive Sleep Apnea

Source: ClinicalTrials.gov NCT03938259 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2024

Primary outcomePrimary: Respiratory Depression Following Opioids — -38.1; -37.1 percentage of change from baseline

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Respiratory Depression Following Opioids	4.0; 2.2	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.