Trial Information
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Inclusion Criteria:
- Children ages 2 years to 18 years with acute leukemia/lymphoma cared for by
physicians in the Division of Hematology/Oncology in the Department of Pediatrics and
receiving sedation for diagnostic/therapeutic lumbar punctures (LPs) in the UW
Pediatric Sedation Program
- Enrollment will occur after the induction phase of chemotherapy.
Exclusion Criteria:
- American Society of Anesthesiology score ≥ 3
- Cardiorespiratory instability
- Allergy to propofol or its components
- Age less than 2 years
- Patients receiving other sedative analgesics
- Patients with an oxygen requirement
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension
Principal Investigator
Gregory Hollman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Institutional Review Board
Study ID:
2003-0470
NCT ID:
NCT00214370
Start Date:
July 2004
Completion Date:
June 2006
Related Keywords:
- Leukemia
- Lymphoma
- pediatric
- acute leukemia/lymphoma
- Leukemia
- Lymphoma
Name | Location |
University of Wisconsin |
Madison,, Wisconsin 53792-5666 |