The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664507

Enrollment

Registered

2012-08-14

Start date

2016-01-31

Completion date

2018-08-31

Last updated

2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Croup, Epinephrine, Administration, Inhalation

Keywords

croup, dose, epinephrine

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.

Interventions

DRUGconventional dose epinephrine

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

DRUGlow dose epinephrine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

6 Months to 5 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—
the incidence of use of additional neublized treatment	30 minutes	—
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
health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom	within 7 days	—

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026