Stridor
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.
Detailed description
The guideline for prevention and treatment of post-extubation stridor in children is inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized corticosteroid is alternative treatment for viral croup. the rationale of this study to evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric post-extubation stridor
Interventions
DRUGfluticasone propionate
Flixotide 1 mg + NSS upto 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
DRUGPlacebo
NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
Sponsors
Ramathibodi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children age between 1 month old - 18 year old who was intubated
Exclusion criteria
* Palliative care * Anatomical abnormalities of airway; subglottic stenosis * Neuromuscular disease with negative inspiratory force \< - 30 mmHg * Need positive pressure after extubation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-extubation stridor | 6 hours | patient who developed stridor after extubation within 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| treatment failure | 24 hour | patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours |
| adverse events | 24 hour | hyperglycemia, oral thrust or GI bleeding |
Countries
Thailand
Outcome results
None listed