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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

August 3, 2012
August 14, 2012
January 9, 2018
January 2016
August 2018   (Final data collection date for primary outcome measure)
the difference of Westley croup score between baseline and 30 minutes after neublized treatment [ Time Frame: 30 minutes ]
Same as current
Complete list of historical versions of study NCT01664507 on ClinicalTrials.gov Archive Site
  • the incidence of use of additional neublized treatment [ Time Frame: 30 minutes ]
  • Westley croup score [ Time Frame: 30, 60, 90, 120, 180, 240 minutes ]
  • 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
  • respiratory rate, oxygen saturation [ Time Frame: 30, 60, 90, 120, 180, 240 minutes ]
  • health care utilization- length of stay in emergency department, admission rate, revisit dut to croup symptom [ Time Frame: within 7 days ]
  • 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.
  • rebound effect [ Time Frame: 180 minutes ]
    the croup score is the same or over than the base line
Same as current
Not Provided
Not Provided
 
The Effect and Safety of Low Dose Nebulized Epinephrine in Croup
The Effect and Safety of Low Dose Nebulized Epinephrine in the Treatment of Croup

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Croup
  • Epinephrine, Administration, Inhalation
  • Drug: conventional dose epinephrine
    conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
  • Drug: low dose epinephrine
    low dose epineprhine : 0.1mg/kg + 0.9% normal saline
  • Active Comparator: conventional dose epinephrine
    L-epinephrine (1:1000) 0.5 mL/kg (maximum 5mL) + normal saline : total 5mL
    Intervention: Drug: conventional dose epinephrine
  • Experimental: low dose epinephrine
    L-epinephrine (1:1000) 0.1 mL/kg (maximum 1mL) + normal saline : total 5mL
    Intervention: Drug: low dose epinephrine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
84
132
August 2018
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Months to 5 Years   (Child)
Yes
Korea, Republic of
 
 
NCT01664507
Croup_01
Yes
Not Provided
Not Provided
Jin Hee Lee, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP