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Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma


N/A
2 Years
18 Years
Not Enrolling
Both
Leukemia, Lymphoma

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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 WisconsinMadison,, Wisconsin  53792-5666