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Effect of Nebulized Epinephrin in the Treatment of Patient's Croup

Protocol summary

Summary
Hypothesis is that there is no difference between Croup's Scorings and discharge's times of patients who will get "Nebulized Epinephrine+ Dexamethason" compare with whom they will get only ordinary care including "Cool Nebulized normal saline+ Dexamethason" . We will divide patients into two groups randomly, intervention and control. First we will measure all of patients for Croup Scoring, Blood pressure, Heart rate and Respiratory rate before treatment. Intervention Group: This patients will be treated by Epinephrine (0.5 mg / kg, max dose: 5 mg) nebulized + Dexamethasone( 0.6 mg / kg, max dose: 8 mg) and we will measure again Croup scoring ( Westley Score), Blood pressure, Heart rate and Respiratory rate on the minutes time of 30, 60, 90 and 120. Control group: This patients will get only Dexamethasone (0.6 mg / kg, max dose: 8 mg) + Cool nebulized normal saline. We will measure again Croup Scoring, Blood pressure, Heart rate and Respiratory rate on the minutes of 30, 60, 90 and 120 as well.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105156491N1
Registration date: 2011-12-03, 1390/09/12
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-12-03, 1390/09/12
Registrant information
Name
Ali Sabbagh
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1313 5075
Email address
alisabbagh@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Nebulized Epinephrin in the Treatment of Patient's Croup
Public title
Effect of Nebulized L-Epinephrin in the Treatment of Patient's Croup
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: All of patients aged between 6 months and 6 years. Exclusion Criteria: patients who are known case of cardiovascular disease; patients whose parents refuse to participate.
Age
From 1 year old to 6 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 174
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
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Pardis Site, Sardasht, Beseij square, PO Box (1884)
City
Arak
Postal code
3848176941
Approval date
2011-04-20, 1390/01/31
Ethics committee reference number
5-106-90

Health conditions studied

1

Description of health condition studied
Croup
ICD-10 code
J05.0
ICD-10 code description
J05.0 Acute obstructive laryngitis [croup]

Primary outcomes

1

Description
Croup score
Timepoint
the minutes of 30, 60, 90 and 120 after treatment.
Method of measurement
Westley Score

Secondary outcomes

1

Description
Blood presure
Timepoint
the minutes of 30, 60, 90 and 120 after treatment.
Method of measurement
physical exam

2

Description
Heart rate
Timepoint
the minutes of 30, 60, 90 and 120 after treatment.
Method of measurement
physical exam

3

Description
Respiratory rate
Timepoint
the minutes of 30, 60, 90 and 120 after treatment.
Method of measurement
physical exam

Intervention groups

1

Description
Intervention: Epinephrine (0.5 mg / kg, max dose: 5 mg) plus normal saline (10 cc) which this coctel will be nebulized for 20 minutes (it is repeatable for 3 times). Also, these patients will receive Dexamethasone (0.6 mg / kg/IM, max dose: 8 mg) while infant or child sits on the mother's arm.
Category
Treatment - Drugs

2

Description
control: nebulized normal saline (it is repeatable for 3 times) associated with Dexamethasone (0.6 mg / kg, max dose: 8 mg) while infant or child sits on the mother's arm.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Aziz Eghbali, Ali Sabbagh
Street address
Amir'Kabir Hospital
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Saeid Changizi Ashtiani
Street address
Arak University of Medical Sciences, Pardis Site, Sardasht, Beseij square, PO Box (1884)
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences and Health Services
Full name of responsible person
Aziz Eghbali
Position
Assistant Professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Site, Sardasht, Beseij square, PO Box (1884)
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 5075
Email
aziz_eghbali@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Aziz Eghbali
Position
Assistant 's proffessor
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Site, Sardasht, Beseij square, PO Box (1884)
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 5075
Email
aziz_eghbali@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Ali Sabbagh
Position
Residence of Pediatric Diseases
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Site, Sardasht, Beseij square, PO Box (1884)
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 86 1313 5075
Email
memcko@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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