In this clinical trial study, patients with moderate to severe croup will be enrolled in two groups with intramuscular Dexamethasone and normal saline nebulizer or intramuscular Dexamethasone (at a single dose of 0.6mg/kg) and nebulized epinephrine (0.5mL of 1:1000 (1mg/ml) in 3ml Normal saline solution for less than 10kg weight and 1mL for more than 10kg weight. In control group, 3ml Normal saline solution will be nebulized. Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105264396N2
Registration date:2011-06-13, 1390/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-13, 1390/03/23
Registrant information
Name
Iraj Mohammadzadeh
Name of organization / entity
Non-communicable pediatric diseases research center
Country
Iran (Islamic Republic of)
Phone
+98 11 1324 2151
Email address
i.mohammadzadeh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University Of Medical Sciences
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-08-23, 1390/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dexamethasone and dexamethasone with nebulised L-epinephrine in treatment of croup.
Public title
The effect of dexamethasone and dexamethasone with nebulised L-epinephrine in treatment of croup.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: children aged 6months to 6years old suffering from croup.
Exclusion criteria: receiving steroid during last month, asthma, pneumonia, congenital heart diseases.
Age
To 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Siences
Street address
Babol,Ganjafrooz Street
City
Babol
Postal code
4731741151
Approval date
2010-02-28, 1388/12/09
Ethics committee reference number
3150
Health conditions studied
1
Description of health condition studied
Croup
ICD-10 code
J05.0
ICD-10 code description
Acute obstructive laryngitis [croup]
Primary outcomes
1
Description
Croup Score
Timepoint
Before treatment, 30min after treatment and 1 hour after treatment
Method of measurement
Number(0-6)
Secondary outcomes
1
Description
Hospitalization, Duration of stay in emergency,Respiratory Rate
Timepoint
nothing
Method of measurement
Yes/No,Hour,Number
Intervention groups
1
Description
In this study, control group, will be treated with 0.6mg/kg intramuscular Dexamethasone at a single dose and 3cc nebulized N/S.
Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring.
Category
Treatment - Drugs
2
Description
In this study, the case group will be treated with 0.6mg/kg intramuscular Dexamethasone at a single dose and nebulized epinephrine (0.5mL of 1:1000 (1mg/mL) in 3mL N/S for less than 10kg weight and 1mL for more than 10kg weight.
Before treatment and 30 and 60 minutes after treatment, croup score and respiratory rate per minute will be calculated for each patient and age, gender, duration of stay in the emergency ward and hospitalization status will be recorded. Croup diagnosis will be based on clinical signs and croup scoring according to asthma and allergy specialist’s scoring.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amircola Pediatrics Hospital
Full name of responsible person
Iraj Mohammadzadeh M.D.Children Subspecialist of Allergy and Immunology
Street address
Babol,Amirkola Children's Hospital
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amrollah Mostafazadeh
Street address
Babol university of medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Amirkola Children's Hospital
Full name of responsible person
Iraj Mohammadzadeh M.D
Position
Subspecialist in Children's Allergy and Immunology
Other areas of specialty/work
Street address
Babol. Amirkola Children's Hospital
City
Babol
Postal code
4731741151
Phone
+98 11 1324 2151
Fax
+98 11 1324 0656
Email
i.mohammadzadeh@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Non-Communicable pediatric diseases research cente, Babol University of Medical Sciences
Full name of responsible person
Iraj Mohammadzadeh M.D
Position
Subspecialist in Children's Allergy and Immunology
Other areas of specialty/work
Street address
Babol, Amirkola Children's Hospital
City
Babol
Postal code
4731741151
Phone
+98 11 1324 2151
Fax
+98 11 1324 0656
Email
i.mohammadzadeh@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Amirkola Children's Hospital
Full name of responsible person
Alireza Norouzi M.D
Position
Pediatric's Resident
Other areas of specialty/work
Street address
Babol, Amirkola Children's Hospital
City
Babol
Postal code
Phone
+98 21 7788 4940
Fax
+98 11 1324 0656
Email
alireza_norouzi2000@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)