An interventional study of Budesonide and Dexamethasone in Stridor, sponsored by Hospital Israelita Albert Einstein. Status unknown at 1 site in Brazil. Open to participants aged 1 Month to 19 Years. Per ClinicalTrials.gov, last updated 2014-02-06.
Sponsored by Hospital Israelita Albert Einstein · Not applicable, Interventional, and Treatment
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.
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.
143 studies on the registry are indexed under Respiratory Sounds; 32 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 75 interventional studies indexed under Respiratory Sounds.
Browse Respiratory Sounds studies →Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.
Drug: Budesonide
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.
Drug: Dexamethasone
The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 2 mg of inhaled budesonide and 3 ml of IV normal saline. If there is an improvement the following maintenance therapy will be instituted for 48 hs and the subjects will receive 2 mg of budesonide q12hs and 3 ml of IV NS q6hs.
Also known as: Pulmicort
The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 8 ml of inhaled normal saline and 0.6 mg/kg of IV dexamethasone. The dexamethasone group will receive 8 ml of inhaled NS q12hs and 0.15 mg/kg/dose of dexamethasone q6hs.
Also known as: Decadron, Hexadrol, Maxidex
The decrease of stridor and respiratory discomfort
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.
Time frame: 6 hours
Number of patients with adverse events
The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.
Time frame: 1 day
The time frame of stridor's and respiratory discomfort's improvements
The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort.
Time frame: 1 hour
The number of patients that will have extubation failure at each arm
Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation.
Time frame: 2 days
The number of inhaled epinephrine doses used in each arms.
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.
Time frame: 2 days
The number of patients who need for non invasive mechanical ventilation or Heliox
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.
Time frame: 2 days
The numbers of bronchoscopies
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.
Time frame: 2 days
This study is status unknown, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Hospital Israelita Albert Einstein