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

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ClinicalTrials.gov Identifier: NCT02056379

Recruitment Status : Unknown

Verified February 2014 by Daniela Nasu Monteiro Medeiros, Hospital Israelita Albert Einstein.
Recruitment status was: Not yet recruiting

First Posted : February 6, 2014

Last Update Posted : February 6, 2014

Sponsor:

Collaborator:

Hospital M'Boi Mirim

Information provided by (Responsible Party):

Daniela Nasu Monteiro Medeiros, Hospital Israelita Albert Einstein

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stridor	Drug: Budesonide Drug: Dexamethasone	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	70 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children
Study Start Date :	March 2014
Estimated Primary Completion Date :	March 2015
Estimated Study Completion Date :	March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Budesonide Dexamethasone acetate

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: Decadron, Hexadrol, Maxidex

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 Name: 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 Name: Decadron, Hexadrol, Maxidex

Outcome Measures

Primary Outcome Measures :

The decrease of stridor and respiratory discomfort [ Time Frame: 6 hours ]
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.

Secondary Outcome Measures :

Number of patients with adverse events [ Time Frame: 1 day ]
The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.
The time frame of stridor's and respiratory discomfort's improvements [ Time Frame: 1 hour ]
The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort.
The number of patients that will have extubation failure at each arm [ Time Frame: 2 days ]
Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation.
The number of inhaled epinephrine doses used in each arms. [ Time Frame: 2 days ]
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.
The number of patients who need for non invasive mechanical ventilation or Heliox [ Time Frame: 2 days ]
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.
The numbers of bronchoscopies [ Time Frame: 2 days ]
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.

Eligibility Criteria

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Ages Eligible for Study:	1 Month to 19 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056379

Contacts

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Contact: Daniela NM Medeiros	5511973347555	daninasu@yahoo.com.br
Contact: Eduardo J Troster	551121511233	troster@einstein.br

Locations

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Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
São Paulo, Brazil, 05652-000
Contact: Daniela NM Medeiros 5511873347555 daninasu@yahoo.com.br
Contact: Eduardo J Troster 551121511233 troster@einstein.br

Sponsors and Collaborators

Hospital Israelita Albert Einstein

Hospital M'Boi Mirim

Investigators

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Principal Investigator:	Daniela NM Medeiros	Hospital Israelita Albert Einstein

More Information

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.

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Responsible Party:	Daniela Nasu Monteiro Medeiros, MD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:	NCT02056379
Other Study ID Numbers:	508177
First Posted:	February 6, 2014 Key Record Dates
Last Update Posted:	February 6, 2014
Last Verified:	February 2014

Keywords provided by Daniela Nasu Monteiro Medeiros, Hospital Israelita Albert Einstein:


stridor laryngitis budesonide dexamethasone children

Additional relevant MeSH terms:

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Respiratory Sounds Signs and Symptoms, Respiratory Dexamethasone Budesonide Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs	Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Bronchodilator Agents Anti-Asthmatic Agents Respiratory System Agents

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