Stridor
Conditions
Keywords
stridor, laryngitis, budesonide, dexamethasone, children
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.
Interventions
DRUGBudesonide
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.
DRUGDexamethasone
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.
Sponsors
Hospital M'Boi Mirim
Hospital Israelita Albert Einstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 19 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Countries
Brazil
Contacts
Primary ContactDaniela NM Medeiros
Backup ContactEduardo J Troster
Outcome results
None listed