The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-08-31

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.

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Detailed Description

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Conditions

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Croup Epinephrine, Administration, Inhalation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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conventional dose epinephrine

L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL

Group Type ACTIVE_COMPARATOR

conventional dose epinephrine

Intervention Type DRUG

conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline

low dose epinephrine

L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL

Group Type EXPERIMENTAL

low dose epinephrine

Intervention Type DRUG

low dose epineprhine : 0.1mg/kg + 0.9% normal saline

Interventions

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conventional dose epinephrine

conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline

Intervention Type DRUG

low dose epinephrine

low dose epineprhine : 0.1mg/kg + 0.9% normal saline

Intervention Type DRUG

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes