Department of Pediatrics, Chitwan Medical College, Bharatpur, Nepal.
Department of Pediatrics, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Pediatr Pulmonol. 2021 Jul;56(7):2292-2301. doi: 10.1002/ppul.25388. Epub 2021 Apr 5.
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.
Stratified (for age and intubation duration) randomized open-label noninferiority trial.
Fifteen-bed pediatric intensive care unit in a lower-middle-income country.
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.
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.
多次预用地塞米松可降低拔管后气道阻塞(PEAO)的风险。但最佳剂量尚不明确。我们计划比较低剂量地塞米松(LDD)(0.25mg/kg/剂量)与高剂量地塞米松(HDD)(0.5mg/kg/剂量)在降低 PEAO 风险方面的作用,LDD 和 HDD 均在 24 小时内预处理。
分层(根据年龄和插管时间)随机开放标签非劣效性试验。
中低收入国家的 15 床儿科重症监护病房。
插管时间超过或等于 48 小时且计划首次拔管的儿童(2023 年 2 月 17 日至 3 月 19 日)。排除上气道疾病、慢性呼吸系统疾病、慢性非甾体抗炎药治疗、皮质类固醇或静脉注射免疫球蛋白在过去 7 天内、有胃肠道出血、高血压和高血糖。
LDD(n=144)或 HDD(n=143)(q6h)共六剂。第五剂后立即计划拔管。非劣效性边界保持在 12%。