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

Stridor Clinical Trial

— BUDEXA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02056379
• Other study ID #: 508177
• Status: Not yet recruiting
• Phase: N/A
• First received: January 23, 2014
• Last updated: February 4, 2014
• Start date: March 2014
• Est. completion date: March 2016

Study information

• Verified date: February 2014
• Source: Hospital Israelita Albert Einstein
• Contact: Daniela NM Medeiros
• Phone: 5511973347555
• Email: daninasu[@]yahoo.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: March 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 19 Years

Eligibility

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 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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Hospital M'Boi Mirim

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Geelhoed GC, Macdonald WB. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol. 1995 Dec;20(6):355-61. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2009 Sep 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of patients with adverse events	The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.	1 day	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No