Trial record 3 of 6 for:    Open Studies | "Laryngitis"

The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Laryngitis
Croup
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 July 22, 2014