Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The decrease of stridor and respiratory discomfort
研究概览
简要总结
The study aims to analyze and compare the clinical effects of using inhaled budesonide or intravenous dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein.
详细描述
The investigators propose to perform a prospective, randomized, controlled and double-blind non inferiority study enrolling 70 children with postextubation stridor. The population will be divided in two groups: group 1 will receive inhaled budesonide and IV NS (intravenous normal saline) and group 2 will receive IV (intravenous) dexamethasone and inhaled normal saline. The study aims to analyze and compare (I would just say compare) the clinical effects of using inhaled budesonide or IV dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients intubated for periods longer than 24hs
- •age between 28 days and than 15 years
- •post extubation stridor must be clinically diagnosticated by a MD
- •informed consent must be obtained
排除标准
- •patients under palliative care
- •presence of neuromuscular disease
- •previous airway pathologies
- •epiglottitis, aspiration of foreign bodies
- •viral laryngitis
- •former airway surgery
- •patients previously included in the study within the same hospital admission
- •corticosteroid use in the 48hs preceding extubation
研究组 & 干预措施
Budesonide
2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.
干预措施: Budesonide (Drug)
Dexamethasone
This group will receive 0,15 mg/kg/dose of intravenous dexamethasone at 6/6 hours and 8 cc of nebulized normal saline at 12/12 hours.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The decrease of stridor and respiratory discomfort
时间窗: 6 hours
The investigators will use the Downes-Raphaelly score as an objective measurement tool of degree of respiratory discomfort. The decrease of Downes-Raphaelly score will be considered as an improvement of patient condition.
次要结局
- Number of patients with adverse events(1 day)
- The time frame of stridor's and respiratory discomfort's improvements(1 hour)
- The number of patients that will have extubation failure at each arm(2 days)
- The number of inhaled epinephrine doses used in each arms.(2 days)
- The number of patients who need for non invasive mechanical ventilation or Heliox(2 days)
- The numbers of bronchoscopies(2 days)
研究者
Daniela Nasu Monteiro Medeiros
MD
Hospital Israelita Albert Einstein