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

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

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.

Study Overview

• Status: Unknown
• Conditions: Stridor
• Intervention / Treatment: Drug: Budesonide; Drug: Dexamethasone

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 05652-000
    • Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Budesonide; 2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.	Drug: Budesonide; The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 2 mg of inhaled budesonide and 3 ml of IV normal saline. If there is an improvement the following maintenance therapy will be instituted for 48 hs and the subjects will receive 2 mg of budesonide q12hs and 3 ml of IV NS q6hs.; Other Names: Pulmicort
Active Comparator: Dexamethasone; 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.	Drug: Dexamethasone; The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 8 ml of inhaled normal saline and 0.6 mg/kg of IV dexamethasone. The dexamethasone group will receive 8 ml of inhaled NS q12hs and 0.15 mg/kg/dose of dexamethasone q6hs.; Other Names: Decadron, Hexadrol, Maxidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The decrease of stridor and respiratory discomfort	The investigators will use the Downes-Raphaelly score as an objective measurement tool of degree of respiratory discomfort. The decrease of Downes-Raphaelly score will be considered as an improvement of patient condition.	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with adverse events	The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.	1 day
The time frame of stridor's and respiratory discomfort's improvements	The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort.	1 hour
The number of patients that will have extubation failure at each arm	Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation.	2 days
The number of inhaled epinephrine doses used in each arms.	The inhaled epinephrine will be used as rescue therapy to absence of improvement. The number of inhaled epinephrine dosage used on each patient will be a measure of efficacy of budesonide or dexamethasone.	2 days
The number of patients who need for non invasive mechanical ventilation or Heliox	The non invasive mechanical ventilation and Heliox are rescue therapies. The number of patients treated with those rescue therapies will be a measure of efficacy of budesonide or dexamethasone.	2 days
The numbers of bronchoscopies	The bronchoscopy will demonstrate the non-inflammatory causes of stridor, such as: vocal cord paralysis, granuloma formation, subglottic stenosis, cricoarytenoid joint disfunction. In these cases, neither dexamethasone nor budesonide will improve clinical conditions.	2 days

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Collaborators: Hospital M'Boi Mirim
• Investigators: Principal Investigator: Daniela NM Medeiros, Hospital israelita Albert Einstein

Publications and helpful links

General Publications

• Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.
• Johnson DW, Jacobson S, Edney PC, Hadfield P, Mundy ME, Schuh S. A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup. N Engl J Med. 1998 Aug 20;339(8):498-503. doi: 10.1056/NEJM199808203390802.
• Geelhoed GC, Macdonald WB. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol. 1995 Dec;20(6):355-61. doi: 10.1002/ppul.1950200604.
• Sinha A, Jayashree M, Singhi S. Aerosolized L-epinephrine vs budesonide for post extubation stridor: a randomized controlled trial. Indian Pediatr. 2010 Apr;47(4):317-22. doi: 10.1007/s13312-010-0060-z. Epub 2009 Sep 3.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: February 4, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: children; dexamethasone; stridor; laryngitis; budesonide
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Budesonide
• Other Study ID Numbers: 508177

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No