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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Hospital Israelita Albert Einstein
Sponsor:
Collaborator:
Hospital M'Boi Mirim
Information provided by (Responsible Party):
Daniela Nasu Monteiro Medeiros, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT02056379
First received: January 23, 2014
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Stridor
Drug: Budesonide
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children

Resource links provided by NLM:


Further study details as provided by Hospital Israelita Albert Einstein:

Primary Outcome Measures:
  • The decrease of stridor and respiratory discomfort [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: March 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   1 Month to 19 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02056379

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

Locations
Brazil
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP) Not yet recruiting
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
Principal Investigator: Daniela NM Medeiros Hospital Israelita Albert Einstein
  More Information

Publications:
Responsible Party: Daniela Nasu Monteiro Medeiros, MD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT02056379     History of Changes
Other Study ID Numbers: 508177
Study First Received: January 23, 2014
Last Updated: February 4, 2014
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Hospital Israelita Albert Einstein:
stridor
laryngitis
budesonide
dexamethasone
children

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Budesonide
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014