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

Primary Purpose

Leukemia, Lymphoma

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Propofol-Fentanyl

Propofol alone

About this trial

This is an interventional treatment trial for Leukemia focused on measuring pediatric, acute leukemia/lymphoma

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin

Outcomes

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

Full Information

NCT ID

NCT00214370

First Posted

September 15, 2005

Last Updated

October 1, 2015

Sponsor

University of Wisconsin, Madison

1. Study Identification

Unique Protocol Identification Number

NCT00214370

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2007

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Lymphoma

Keywords

pediatric, acute leukemia/lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Propofol-Fentanyl

Intervention Type

Drug

Intervention Name(s)

Propofol alone

Primary Outcome Measure Information:

Title

Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension

Secondary Outcome Measure Information:

Title

Patient/family preference, ease of induction, and recovery pattern

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory Hollman, MD

Organizational Affiliation

University of Wisconsin, Madison

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

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

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