The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Epinephrine, Administration, Inhalation; Croup

Treatments: Drug: low dose epinephrine; Drug: conventional dose epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01664507

Croup_01

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

conventional dose epinephrine

Active Comparator group

Description:

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

Treatment:

Drug: conventional dose epinephrine

low dose epinephrine

Experimental group

Description:

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

Treatment:

Drug: low dose epinephrine