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The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Primary Purpose

Croup, Epinephrine, Administration, Inhalation

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

conventional dose epinephrine

low dose epinephrine

About this trial

This is an interventional treatment trial for Croup focused on measuring croup, dose, epinephrine

Eligibility Criteria

6 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional dose epinephrine

low dose epinephrine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the incidence of use of additional neublized treatment

Westley croup score

the side effect of epinephrine

Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor

respiratory rate, oxygen saturation

health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom

treatment failure

after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.

rebound effect

the croup score is the same or over than the base line

Full Information

NCT ID

NCT01664507

First Posted

August 3, 2012

Last Updated

January 6, 2018

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01664507

Brief Title

The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

August 2018 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Croup, Epinephrine, Administration, Inhalation

Keywords

croup, dose, epinephrine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conventional dose epinephrine

Arm Type

Active Comparator

Arm Description

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

Arm Title

low dose epinephrine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

conventional dose epinephrine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

low dose epinephrine

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

the incidence of use of additional neublized treatment

Time Frame

30 minutes

Title

Westley croup score

Time Frame

30, 60, 90, 120, 180, 240 minutes

Title

the side effect of epinephrine

Description

Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor

Time Frame

participants will be followed for the duration of ED stay

Title

respiratory rate, oxygen saturation

Time Frame

30, 60, 90, 120, 180, 240 minutes

Title

health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom

Time Frame

within 7 days

Title

treatment failure

Description

after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.

Time Frame

30min after 2nd epinephrine nebulizer

Title

rebound effect

Description

the croup score is the same or over than the base line

Time Frame

180 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

110-744

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Hee Lee, Professor

Phone

+82-2-2072-4910

gienee74@gmail.com

First Name & Middle Initial & Last Name & Degree

Jin Hee Lee, Professor

First Name & Middle Initial & Last Name & Degree

Hyuksool kwon, Professor

12. IPD Sharing Statement

Citations:

PubMed Identifier

30878411

Citation

Lee JH, Jung JY, Lee HJ, Kim DK, Kwak YH, Chang I, Kwon H, Choi YJ, Park JW, Paek SH, Cho JH. Efficacy of low-dose nebulized epinephrine as treatment for croup: A randomized, placebo-controlled, double-blind trial. Am J Emerg Med. 2019 Dec;37(12):2171-2176. doi: 10.1016/j.ajem.2019.03.012. Epub 2019 Mar 8.

Results Reference

derived

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The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

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