Twenty-four-hour pretreatment with low dose (0.25 mg/kg/dose) versus high dose (0.5 mg/kg/dose) dexamethasone in reducing the risk of postextubation airway obstruction in children: A randomized open-label noninferiority trial
Abstract
Objective
Multidose dexamethasone pretreatment reduces risk of postextubation airway obstruction (PEAO). However, its optimal dose is not known. We planned to compare 24 h pretreatment with low-dose dexamethasone (LDD) (0.25 mg/kg/dose) versus high-dose dexamethasone (HDD) (0.5 mg/kg/dose) in reducing risk of PEAO.
Design
Stratified (for age and intubation duration) randomized open-label noninferiority trial.
Setting
Fifteen-bed pediatric intensive care unit in a lower-middle-income country.
Patients
Children (3 months–12 years) intubated for more than or equal to 48 h and planned for first extubation (February 17–March 19). Upper airway conditions, chronic respiratory diseases, chronic NSAID therapy, steroid, or intravenous immunoglobulin in the last 7 days, presence of gastrointestinal bleeding, hypertension, and hyperglycemia were exclusions.
Interventions
LDD (n = 144) or HDD (n = 143) (q6h) for a total of six doses. Extubation was planned immediately after fifth dose. Noninferiority margin was kept at 12% from baseline.
CONFLICT OF INTERESTS
The authors declare that there are no conflict of interests.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
