Status:
COMPLETED
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
The hypothesis of the study is that propofol-fentanyl sedation for lumbar punctures in children with acute leukemia/lymphoma results in fewer adverse events than propofol sedation alone. Secondary hyp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00214370
Start Date
July 1 2004
End Date
June 1 2006
Last Update
October 5 2015
Active Locations (1)
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1
University of Wisconsin
Madison, Wisconsin, United States, 53792