Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Information source: University of Wisconsin, Madison
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Leukemia; Lymphoma
Intervention: Propofol-Fentanyl (Drug); Propofol alone (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
Gregory Hollman, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison
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 hypotheses state that propofol-fentanyl sedation results in a better
sedation induction, recovery profile and is preferred by patients/families. The study is a
double blind, randomized, placebo controlled crossover study. Following the induction phase
of chemotherapy, children will be randomized in a crossover manner to receive either
fentanyl-propofol or propofol-placebo for future lumbar punctures. Patients will be studied
on two separate occasions, once with propofol-placebo (normal saline) and once with
propofol-fentanyl. Children will be monitored continuously by pulse oximetry,
electrocardiogram (ECG) and direct nursing and physician observation during the sedation in
accordance with the University of Wisconsin (UW) Pediatric Policy and Procedure. Propofol
will be titrated to a Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score of ≤ 7
for all children. Oxygen saturation, respiratory rate, heart rate and blood pressure will be
recorded every 3 minutes by a study investigator during sedation.
Clinical Details
Official title: Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension
Secondary outcome: Patient/family preference, ease of induction, and recovery pattern
Eligibility
Minimum age: 2 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University of Wisconsin, Madison, Wisconsin 53792, United States
Additional Information
Starting date: July 2004
Ending date: June 2006
Last updated: July 16, 2007
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