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
  Purpose

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.


Condition Intervention
Leukemia
Lymphoma
Drug: Propofol-Fentanyl
Drug: Propofol alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Propofol Versus Propofol-Fentanyl as Sedation For Lumbar Puncture in Children With Acute Leukemia/Lymphoma

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension

Secondary Outcome Measures:
  • Patient/family preference, ease of induction, and recovery pattern

Estimated Enrollment: 40
Study Start Date: July 2004
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214370

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Gregory Hollman, MD University of Wisconsin, Madison
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00214370     History of Changes
Other Study ID Numbers: 2003-0470
Study First Received: September 15, 2005
Last Updated: July 16, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
pediatric
acute leukemia/lymphoma

Additional relevant MeSH terms:
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Propofol
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on September 30, 2014