The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

This study is not yet open for participant recruitment.

Verified August 2012 by Seoul National University Hospital

Sponsor:

Information provided by (Responsible Party):

Jin Hee Lee, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01664507

First received: August 3, 2012

Last updated: August 9, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 3, 2012
Last Updated Date	August 9, 2012
Start Date ^ICMJE	September 2012
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 9, 2012)	the difference of Westley croup score between baseline and 30 minutes after neublized treatment [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01664507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 9, 2012)	the incidence of use of additional neublized treatment [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ] Westley croup score [ Time Frame: 30, 60, 90, 120, 180, 240 minutes ] [ Designated as safety issue: Yes ] the side effect of epinephrine [ Time Frame: participants will be followed for the duration of ED stay ] [ Designated as safety issue: Yes ] Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor respiratory rate, oxygen saturation [ Time Frame: 30, 60, 90, 120, 180, 240 minutes ] [ Designated as safety issue: Yes ] health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom [ Time Frame: within 7 days ] [ Designated as safety issue: Yes ] treatment failure [ Time Frame: 30min after 2nd epinephrine nebulizer ] [ Designated as safety issue: Yes ] after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared. rebound effect [ Time Frame: 180 minutes ] [ Designated as safety issue: Yes ] the croup score is the same or over than the base line
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect and Safety of Low Dose Nebulized Epinephrine in Croup
Official Title ^ICMJE	The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup
Brief Summary	Croup is common illness presenting emergency department with dyspnea. The main treatment for croup is nebulized L-epinephrine and steroid. The study for the dose of nebulized L-epinephrine is restricted that the study of comparision between racemic epinephrine and L-epinephrine. The investigators conducted this study to compare the effectiveness of low dose L-epinephrine with conventional dose L-epinephrine.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Croup Epinephrine Neublizer Treatment
Intervention ^ICMJE	Drug: conventional dose epinephrine conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline Drug: low dose epinephrine low dose epineprhine : 0.05mg/kg + normal saline
Study Arm (s)	Active Comparator: conventional dose epinephrine Intervention: Drug: conventional dose epinephrine Experimental: low dose epinephrine Intervention: Drug: low dose epinephrine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	132
Estimated Completion Date	August 2013
Estimated Primary Completion Date	August 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: croup children between 6 month and 5 years old Westley croup score between 3 and 11 Exclusion Criteria: underlying lung or heart disase contra indication to dexamethasone immune deficient state preterm birth previous intubation or apnea history
Gender	Both
Ages	6 Months to 5 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01664507
Other Study ID Numbers ^ICMJE	Croup_01
Has Data Monitoring Committee	Yes
Responsible Party	Jin Hee Lee, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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