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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214370
First received: September 15, 2005
Last updated: July 16, 2007
Last verified: July 2007

September 15, 2005
July 16, 2007
July 2004
Not Provided
Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension
Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension.
Complete list of historical versions of study NCT00214370 on ClinicalTrials.gov Archive Site
Patient/family preference, ease of induction, and recovery pattern
Patient/family preference, ease of induction, and recovery pattern.
Not Provided
Not Provided
 
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma
Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Leukemia
  • Lymphoma
  • Drug: Propofol-Fentanyl
  • Drug: Propofol alone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2006
Not Provided

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00214370
2003-0470
Not Provided
Not Provided
University of Wisconsin, Madison
Not Provided
Principal Investigator: Gregory Hollman, MD University of Wisconsin, Madison
University of Wisconsin, Madison
July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP