The Effect and Safety of Low Dose Nebulized Epinephrine in Croup
1 other identifier
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJanuary 9, 2018
January 1, 2018
2.6 years
August 3, 2012
January 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the difference of Westley croup score between baseline and 30 minutes after neublized treatment
30 minutes
Secondary Outcomes (7)
the incidence of use of additional neublized treatment
30 minutes
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
respiratory rate, oxygen saturation
30, 60, 90, 120, 180, 240 minutes
health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom
within 7 days
- +2 more secondary outcomes
Study Arms (2)
conventional dose epinephrine
ACTIVE COMPARATORL-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL
low dose epinephrine
EXPERIMENTALL-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL
Interventions
conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
Eligibility Criteria
You may qualify if:
- croup children between 6 month and 5 years old
- Westley croup score between 3 and 11
You may not qualify if:
- underlying lung or heart disase
- contra indication to dexamethasone
- immune deficient state
- preterm birth
- previous intubation or apnea history
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 30878411DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 3, 2012
First Posted
August 14, 2012
Study Start
January 1, 2016
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
January 9, 2018
Record last verified: 2018-01