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

Information source: Hospital Israelita Albert Einstein
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stridor

Intervention: Budesonide (Drug); Dexamethasone (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Hospital Israelita Albert Einstein

Official(s) and/or principal investigator(s):
Daniela NM Medeiros, Principal Investigator, Affiliation: Hospital Israelita Albert Einstein

Overall contact:
Daniela NM Medeiros, Phone: 5511973347555, Email: daninasu@yahoo.com.br

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 Details

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

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

Primary outcome: The decrease of stridor and respiratory discomfort

Secondary outcome:

Number of patients with adverse events

The time frame of stridor's and respiratory discomfort's improvements

The number of patients that will have extubation failure at each arm

The number of inhaled epinephrine doses used in each arms.

The number of patients who need for non invasive mechanical ventilation or Heliox

The numbers of bronchoscopies

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

Minimum age: 1 Month. Maximum age: 19 Years. Gender(s): Both.

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

Locations and Contacts

Daniela NM Medeiros, Phone: 5511973347555, Email: daninasu@yahoo.com.br

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP), São Paulo 05652-000, Brazil; Not yet recruiting
Daniela NM Medeiros, Phone: 5511873347555, Email: daninasu@yahoo.com.br
Eduardo J Troster, Phone: 551121511233, Email: troster@einstein.br
Additional Information

Related 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.

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.

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

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.

Starting date: March 2014
Last updated: February 4, 2014

Page last updated: August 23, 2015

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