The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Phase 4

• Conditions: Croup; Epinephrine, Administration, Inhalation
• Interventions: Drug: conventional dose epinephrine; Drug: low dose epinephrine

• Registration Number: NCT01664507
• Lead Sponsor: Seoul National University Hospital

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-03
• Study First Submitted QC: 2012-08-09
• Study First Posted: 2012-08-14
• Study Start: 2016-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-06
• Last Update Posted: 2018-01-09
• Primary Completion: 2018-08
• Study Completion: 2018-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• croup children between 6 month and 5 years old
• Westley croup score between 3 and 11

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Exclusion Criteria

• underlying lung or heart disase
• contra indication to dexamethasone
• immune deficient state
• preterm birth
• previous intubation or apnea history

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional dose epinephrine	conventional dose epinephrine	L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL
low dose epinephrine	low dose epinephrine	L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL

Primary Outcome Measures

Name	Time	Method
the difference of Westley croup score between baseline and 30 minutes after neublized treatment	30 minutes

Secondary Outcome Measures

Name	Time	Method
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	participants will be followed for the duration of ED stay	Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor
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	30min after 2nd epinephrine nebulizer	after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.
rebound effect	180 minutes	the croup score is the same or over than the base line

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of