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The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

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ClinicalTrials.gov Identifier: NCT01664507
Recruitment Status : Recruiting
First Posted : August 14, 2012
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Jin Hee Lee, Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Croup Epinephrine, Administration, Inhalation Drug: conventional dose epinephrine Drug: low dose epinephrine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup
Study Start Date : January 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: conventional dose epinephrine
L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL
Drug: conventional dose epinephrine
conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline

Experimental: low dose epinephrine
L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL
Drug: low dose epinephrine
low dose epineprhine : 0.1mg/kg + 0.9% normal saline




Primary Outcome Measures :
  1. the difference of Westley croup score between baseline and 30 minutes after neublized treatment [ Time Frame: 30 minutes ]

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

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

  7. rebound effect [ Time Frame: 180 minutes ]
    the croup score is the same or over than the base line



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01664507


Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin Hee Lee, Professor    +82-2-2072-4910    gienee74@gmail.com   
Principal Investigator: Jin Hee Lee, Professor         
Principal Investigator: Hyuksool kwon, Professor         
Sponsors and Collaborators
Seoul National University Hospital

Responsible Party: Jin Hee Lee, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01664507     History of Changes
Other Study ID Numbers: Croup_01
First Posted: August 14, 2012    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

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

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