Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children (BUDEXA)
|ClinicalTrials.gov Identifier: NCT02056379|
Recruitment Status : Unknown
Verified February 2014 by Daniela Nasu Monteiro Medeiros, Hospital Israelita Albert Einstein.
Recruitment status was: Not yet recruiting
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stridor||Drug: Budesonide Drug: Dexamethasone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||March 2016|
Active Comparator: Budesonide
2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.
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.
Other Name: Pulmicort
Active Comparator: 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.
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.
Other Name: Decadron, Hexadrol, Maxidex
- The decrease of stridor and respiratory discomfort [ Time Frame: 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.
- Number of patients with adverse events [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056379
|Contact: Daniela NM Medeirosemail@example.com|
|Contact: Eduardo J Trosterfirstname.lastname@example.org|
|Principal Investigator:||Daniela NM Medeiros||Hospital Israelita Albert Einstein|