Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- fluticasone propionate
- Conditions
- Stridor
- Sponsor
- Ramathibodi Hospital
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- post-extubation stridor
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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
Investigators
Nattachai Anantasit
Assistant Professor
Ramathibodi Hospital
Eligibility Criteria
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
Arms & Interventions
fluticasone propionate
Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation
Intervention: fluticasone propionate
placebo
Normal saline (NSS) 4 ml nebulized after extubation
Intervention: Placebo
Outcomes
Primary Outcomes
post-extubation stridor
Time Frame: 6 hours
patient who developed stridor after extubation within 6 hours
Secondary Outcomes
- treatment failure(24 hour)
- adverse events(24 hour)