Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children
- Registration Number
- NCT02056379
- Lead Sponsor
- Hospital Israelita Albert Einstein
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Budesonide Budesonide 2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline. Dexamethasone 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.
- Primary Outcome Measures
Name Time Method The decrease of stridor and respiratory discomfort 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.
- Secondary Outcome Measures
Name Time Method Number of patients with adverse events 1 day The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.
The time frame of stridor's and respiratory discomfort's improvements 1 hour The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort.
The number of patients that will have extubation failure at each arm 2 days Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation.
The number of inhaled epinephrine doses used in each arms. 2 days The inhaled epinephrine will be used as rescue therapy to absence of improvement. The number of inhaled epinephrine dosage used on each patient will be a measure of efficacy of budesonide or dexamethasone.
The number of patients who need for non invasive mechanical ventilation or Heliox 2 days The non invasive mechanical ventilation and Heliox are rescue therapies. The number of patients treated with those rescue therapies will be a measure of efficacy of budesonide or dexamethasone.
The numbers of bronchoscopies 2 days The bronchoscopy will demonstrate the non-inflammatory causes of stridor, such as: vocal cord paralysis, granuloma formation, subglottic stenosis, cricoarytenoid joint disfunction. In these cases, neither dexamethasone nor budesonide will improve clinical conditions.
Trial Locations
- Locations (1)
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
🇧🇷São Paulo, Brazil