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

Stridor Clinical Trial

Official title: Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stridor

• NCT number: NCT02056379
• Study type: Interventional
• Source: Hospital Israelita Albert Einstein
• Contact: Daniela NM Medeiros
• Phone: 5511973347555
• Email: daninasu@yahoo.com.br
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2014
• Completion date: March 2016