The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Study Overview
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Brief Summary
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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.

Official Title
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The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup

Conditions
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Croup, Epinephrine, Administration, Inhalation

Intervention / Treatment
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* Drug: conventional dose epinephrine
* Drug: low dose epinephrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional dose epinephrine<br>L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL | Drug: conventional dose epinephrine<br>* conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline<br>|
| Experimental: low dose epinephrine<br>L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL | Drug: low dose epinephrine<br>* low dose epineprhine : 0.1mg/kg + 0.9% normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the difference of Westley croup score between baseline and 30 minutes after neublized treatment |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of use of additional neublized treatment |  | 30 minutes | 
| Westley croup score |  | 30, 60, 90, 120, 180, 240 minutes | 
| the side effect of epinephrine | Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor | participants will be followed for the duration of ED stay | 
| respiratory rate, oxygen saturation |  | 30, 60, 90, 120, 180, 240 minutes | 
| health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom |  | within 7 days | 
| treatment failure | after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared. | 30min after 2nd epinephrine nebulizer | 
| rebound effect | the croup score is the same or over than the base line | 180 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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croup, dose, epinephrine