Nebulized Corticosteroid for Post Extubation Stridor in Children

Mahidol University

Status and phase: Completed; Phase 3

Conditions: Stridor

Treatments: Drug: Placebo; Drug: fluticasone propionate

Study type: Interventional

Funder types: Other

Identifiers

NCT02523820

ID10-57-18

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.

Full 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

Enrollment: 144 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

fluticasone propionate

Experimental group

Description:

Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation

Treatment:

Drug: fluticasone propionate

placebo

Placebo Comparator group

Description:

Normal saline (NSS) 4 ml nebulized after extubation

Treatment:

Drug: Placebo