Clinical trial NCT02056379: Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children
Official title: Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stridor
Keywords: stridor
laryngitis
budesonide
dexamethasone
children
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Hospital M'Boi Mirim
First posted: 2014-02-06
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The decrease of stridor and respiratory discomfort
timeFrame: 6 hours
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: 1 day
measure: The time frame of stridor's and respiratory discomfort's improvements
timeFrame: 1 hour
measure: The number of patients that will have extubation failure at each arm
timeFrame: 2 days
measure: The number of inhaled epinephrine doses used in each arms.
timeFrame: 2 days
measure: The number of patients who need for non invasive mechanical ventilation or Heliox
timeFrame: 2 days
measure: The numbers of bronchoscopies
timeFrame: 2 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Daniela NM Medeiros
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1056/NEJM199408043310501.
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. doi: 10.1056/NEJM199808203390802.
citation: 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.
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. doi: 10.1007/s13312-010-0060-z. Epub 2009 Sep 3.