FindTrial
Sign In

Retrospective evaluation of safety and efficacy of off-labled drug in pediatric population

Retrospective evaluation of safety and efficacy of off-labled drug in pediatric population

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0001979
Enrollment
200000
Registered
2016-07-25
Start date
2016-07-31
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Pediatric patients <18 years old who received the off-labeled medication since 2005

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
adverse effect—

Countries

Korea, Republic of

Contacts

Public ContactHee-Soo Kim

Seoul National University Hospital

muslab@hanmail.net

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026