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Trial registered on ANZCTR


Registration number
ACTRN12610000759099
Ethics application status
Approved
Date submitted
7/09/2010
Date registered
14/09/2010
Date last updated
18/02/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Three Doses of Nebulized Epinephrine in Post-Extubation Croup
Scientific title
In infants and children experiencing post-extubation stridor, is a 0.5, 2.5 or 5ml dose of Nebulized L-Epinephrine more effective in reducing stridor (Westley score)? A Prospective Randomized Double-Blind Study
Secondary ID [1] 252646 0
not applicable
Universal Trial Number (UTN)
U1111-1116-8338
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
upper airway obstruction 258137 0
croup 258138 0
endotracheal intubation 258139 0
respiratory failure 258140 0
mechanical ventilation 258141 0
extubation failure 258142 0
Condition category
Condition code
Respiratory 258319 258319 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:nebulized l-epinephrine (1:1000)
Doses: 0.5 mL or 2.5 mL or 5 mL
Mode of administration: nebulization by face mask
Duration: 15 minutes
Patients will be assigened to one of three study treatments at 15 minutes post-extubation: 5 mL of l-adrenaline 1:1000 (group 1), 2.5 mL of l-adrenaline 1:1000 (group 2) or 0.5 mL of l-adrenaline 1:1000 (group 3). If the amount of l-epinephrine was less than 5 mL, isotonic saline was added until the volume achieved 5 mL. Research nurse will administer nebulizations over 15 minutes with a small, tight-fitting plastic face mask with an updraft nebulizer (Hudson RCI, Teleflex Medical, USA) connected to a source of pressurized oxygen with continuous flow of 100% oxygen at 5 L/min. The nebulizers will be administered until empty.
Intervention code [1] 257155 0
Treatment: Drugs
Comparator / control treatment
Dose comparison

Drug: l-epinephrine 1:1000 (1 mg)
Doses: 0.5 mL (0.5 mg) or 2.5 mL (2.5 mg) or 5 mL (5 mg)
Mode of administration: nebulization by face mask
Duration: 15 minutes
Control group
Dose comparison

Outcomes
Primary outcome [1] 259172 0
Mean change in the post-extubation stridor score (Westley score). The Westley score evaluates five clinical parameters that are related to the degree of upper airway obstruction. The scoring system ranges from 0 to 17 points, with 17 points indicating the most severe stridor.
Timepoint [1] 259172 0
Timepoints: at baseline (0 minute) and at 20, 40, 60, and 180 minutes after epinephrine nebulization
Secondary outcome [1] 265516 0
respiratory rate (breaths per minute) will be continuously monitored by a multiparameter bedside monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [1] 265516 0
at baseline (0 minute) and at 20, 40, 60, and 180 minutes after epinephine nebulization
Secondary outcome [2] 265517 0
heart rate (beats per minute) will be continuously monitored by a multiparameter bedside monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [2] 265517 0
at baseline (0 minute) and at 20, 40, 60, and 180 minutes after epinephrine nebulization
Secondary outcome [3] 265518 0
non-invasive blood pressure (mmHg) will be monitored by a multiparameter monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [3] 265518 0
at baseline (0 minute) and at 20, 40, 60, and 180 minutes after epinephrine nebulization
Secondary outcome [4] 265519 0
oxygen saturation (%) on pulse oximetry will be continuously monitored by a bedside multiparameter monitor (DX 2020, Dixtal, Sao Paulo, Brazil)
Timepoint [4] 265519 0
at baseline (0 minute) and at 20, 40, 60, and 180 minutes after epinephrine nebulization

Eligibility
Key inclusion criteria
Patients presenting hoarseness, a barking cough and inspiratory stridor after extubation and a Westley score more than 3.
Minimum age
1 Months
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous history of subglottic stenosis, laryngomalacia, infectious croup or use of corticosteroids within 48 hours prior to extubation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule (study pharmacist) who was "off-site" (Department of Pharmacy) and had no contact with the study participants
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation by using a computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment outside Australia
Country [1] 2854 0
Brazil
State/province [1] 2854 0

Funding & Sponsors
Funding source category [1] 257611 0
Hospital
Name [1] 257611 0
Hospital do Servidor Publico Municipal
Country [1] 257611 0
Brazil
Primary sponsor type
Individual
Name
Paulo Sergio Lucas da Silva
Address
Pediatric Intensive Care Unit, Department of Pediatrics
Rua Castro Alves, 60
Aclimacao, Sao Paulo
01532-900
Country
Brazil
Secondary sponsor category [1] 256833 0
None
Name [1] 256833 0
Address [1] 256833 0
Country [1] 256833 0
Other collaborator category [1] 251485 0
Individual
Name [1] 251485 0
Simone Brasil Oliveira Iglesias
Address [1] 251485 0
Estrada do Lutero, 1460 - Residencial Paisagem Renoir III - Granja Vianna - Cotia - Sao Paulo
06715-400
Country [1] 251485 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259627 0
Ethics Committee
Ethics committee address [1] 259627 0
Ethics committee country [1] 259627 0
Brazil
Date submitted for ethics approval [1] 259627 0
Approval date [1] 259627 0
24/05/2010
Ethics approval number [1] 259627 0
196/2010

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31614 0
Address 31614 0
Country 31614 0
Phone 31614 0
Fax 31614 0
Email 31614 0
Contact person for public queries
Name 14861 0
Paulo Sergio Lucas da Silva
Address 14861 0
Hospital do Servidor Publico Municipal, Pediatric Intensive Care Unit
Rua Castro Alves, 60, Aclimacao, Sao Paulo, Brazil
01532-900
Country 14861 0
Brazil
Phone 14861 0
+551133972817
Fax 14861 0
Email 14861 0
psls.nat@terra.com.br
Contact person for scientific queries
Name 5789 0
Paulo Sergio Lucas da Silva
Address 5789 0
Hospital do Servidor Publico Municipal, Pediatric Intensive Care Unit
Rua Castro Alves, 60, Aclimacao, Sao Paulo, Brazil
01532-900
Country 5789 0
Brazil
Phone 5789 0
+551133972817
Fax 5789 0
Email 5789 0
psls.nat@terra.com.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.