The Effect and Safety of Low Dose Nebulized Epinephrine in Croup

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Seoul National University Hospital.
Recruitment status was  Not yet recruiting
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

August 3, 2012
August 9, 2012
September 2012
August 2013   (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 ] [ Designated as safety issue: Yes ]
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 ] [ 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
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Croup
  • Epinephrine Neublizer Treatment
  • Drug: conventional dose epinephrine
    conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
  • Drug: low dose epinephrine
    low dose epineprhine : 0.05mg/kg + normal saline
  • Active Comparator: conventional dose epinephrine
    Intervention: Drug: conventional dose epinephrine
  • Experimental: low dose epinephrine
    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.
 
Not yet recruiting
132
August 2013
August 2013   (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
Both
6 Months to 5 Years
Yes
Korea, Republic of
 
NCT01664507
Croup_01
Yes
Jin Hee Lee, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
August 2012

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