The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

January 6, 2018 updated by: Jin Hee Lee, Seoul National University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Jin Hee Lee, Professor
        • Principal Investigator:
          • Hyuksool kwon, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: conventional dose epinephrine
L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL
Drug: conventional dose epinephrine
conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
EXPERIMENTAL: low dose epinephrine
L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL
Drug: low dose epinephrine
low dose epineprhine : 0.1mg/kg + 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of use of additional neublized treatment
Time Frame: 30 minutes
30 minutes
Westley croup score
Time Frame: 30, 60, 90, 120, 180, 240 minutes
30, 60, 90, 120, 180, 240 minutes
the side effect of epinephrine
Time Frame: participants will be followed for the duration of ED stay
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
Time Frame: 30, 60, 90, 120, 180, 240 minutes
30, 60, 90, 120, 180, 240 minutes
health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom
Time Frame: within 7 days
within 7 days
treatment failure
Time Frame: 30min after 2nd epinephrine nebulizer
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
Time Frame: 180 minutes
the croup score is the same or over than the base line
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

August 1, 2018

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

August 9, 2012

First Posted (ESTIMATE)

August 14, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 6, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Croup_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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