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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214370
• Other study ID #: 2003-0470
• Status: Completed
• Phase: N/A
• First received: September 15, 2005
• Last updated: October 1, 2015
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: July 2007
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma

Intervention

Drug:
• Propofol-Fentanyl

• Propofol alone

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fewer adverse cardiorespiratory events defined as oxygen desaturations and hypotension
Secondary	Patient/family preference, ease of induction, and recovery pattern