The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Croup Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01664507
• Other study ID #: Croup_01
• Status: Recruiting
• Phase: Phase 4
• First received: August 3, 2012
• Last updated: January 6, 2018
• Start date: January 2016
• Est. completion date: August 2018

Study information

• Verified date: January 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Croup
• Epinephrine, Administration, Inhalation

Intervention

Drug:
• conventional dose epinephrine
conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
• low dose epinephrine
low dose epineprhine : 0.1mg/kg + 0.9% normal saline

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the difference of Westley croup score between baseline and 30 minutes after neublized treatment		30 minutes
Secondary	the incidence of use of additional neublized treatment		30 minutes
Secondary	Westley croup score		30, 60, 90, 120, 180, 240 minutes
Secondary	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
Secondary	respiratory rate, oxygen saturation		30, 60, 90, 120, 180, 240 minutes
Secondary	health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom		within 7 days
Secondary	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
Secondary	rebound effect	the croup score is the same or over than the base line	180 minutes