Retrospective evaluation of safety and efficacy of off-labled drug in pediatric populatio
Not Applicable
- Conditions
- Not Applicable
- Registration Number
- KCT0001979
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 200000
Inclusion Criteria
Pediatric patients <18 years old who received the off-labeled medication since 2005
Exclusion Criteria
none
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2.Vital sign - inotropics/vasopressor ;3.Neurophysiologic monitoring - EEG, BIS;4. Biochemical variable- ? Immunoglobulin, cytokine, B-type natriuretic peptide;1. Efficacy variable 1)Sedatives: sedatino scale 2)Analgesics and local anesthetics: FLACC scale,? Oucher scale, Visual analogue scale 3)Antibiotics: fever. lab finding, radiologic finding, clinical findings 4)Anticancer drug: change in size of cancer and staging, radiologic finding, clinical manifestation, mortality, 5)Antiepileptic drug: relief of symptom, EEG finding
- Secondary Outcome Measures
Name Time Method adverse effect