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The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

This study is not yet open for participant recruitment.
Verified August 2012 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jin Hee Lee, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01664507
First received: August 3, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Croup
Epinephrine Neublizer Treatment
 Drug: conventional dose epinephrine
Drug: low dose epinephrine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the difference of Westley croup score between baseline and 30 minutes after neublized treatment [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the incidence of use of additional neublized treatment [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
  • Westley croup score [ Time Frame: 30, 60, 90, 120, 180, 240 minutes ] [ Designated as safety issue: Yes ]
  • the side effect of epinephrine [ Time Frame: participants will be followed for the duration of ED stay ] [ Designated as safety issue: Yes ]
    Hypertension, tachycardia : more than 95th percentile for age Arrythmia Pallor Tremor

  • respiratory rate, oxygen saturation [ Time Frame: 30, 60, 90, 120, 180, 240 minutes ] [ Designated as safety issue: Yes ]
  • health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom [ Time Frame: within 7 days ] [ Designated as safety issue: Yes ]
  • treatment failure [ Time Frame: 30min after 2nd epinephrine nebulizer ] [ Designated as safety issue: Yes ]
    after additional nebulized epineprhine at 30 minutes, as the croup scrore is higher than baselin, the blinding is cleared.

  • rebound effect [ Time Frame: 180 minutes ] [ Designated as safety issue: Yes ]
    the croup score is the same or over than the base line


Estimated Enrollment: 132
Study Start Date: September 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional dose epinephrine Drug: conventional dose epinephrine
conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
Experimental: low dose epinephrine Drug: low dose epinephrine
low dose epineprhine : 0.05mg/kg + normal saline

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01664507

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jin Hee Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01664507     History of Changes
Other Study ID Numbers: Croup_01
Study First Received: August 3, 2012
Last Updated: August 9, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
croup, dose, epinephrine

Additional relevant MeSH terms:
Croup
Laryngitis
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Mydriatics
Adrenergic alpha-Agonists
Sympathomimetics
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013