Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children (BUDEXA)

Hospital Israelita Albert Einstein

Status: Unknown

Conditions: Stridor

Treatments: Drug: Dexamethasone; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT02056379

508177

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 1 month to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Budesonide

Active Comparator group

Description:

2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.

Treatment:

Drug: Budesonide

Dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Dexamethasone