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A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream


N/A
N/A
22 Years
Open (Enrolling)
Both
Malignant Neoplasm

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Trial Information

A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream


PRIMARY OBJECTIVES:

I. To determine whether the application of a topical anesthetic (EMLA cream) to the LP site
will decrease the total dose of propofol administered to pediatric oncology patients who are
being sedated for LPs compared to application of a topical placebo cream.

SECONDARY OBJECTIVES:

I. To determine whether the use of EMLA cream decreases complication rates from sedation.

II. To determine whether the use of EMLA cream decreases traumatic lumbar punctures.

III. To determine whether the use of EMLA cream shortens recovery time. IV. To determine
practitioner and parent satisfaction with the use of EMLA cream.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by
standard sedation with fentanyl citrate and propofol.

ARM II: Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP
followed by standard sedation with fentanyl citrate and propofol.

After completion of study treatment, patients are followed up within 1 week.


Inclusion Criteria:



Pediatric oncology patients undergoing a lumbar puncture in the Pediatric Sedation Suite;
patients may or may not be receiving intrathecal chemotherapy

Exclusion Criteria:

Patients undergoing additional procedures during the same anesthetic such as bone marrow
aspirate or biopsy will be excluded because they will likely require higher doses of
propofol than those undergoing LP alone Patients who are allergic to or not tolerant of
EMLA cream, propofol, or fentanyl will be excluded Patients who are pregnant will be
excluded Patients having their LPs done by students will be excluded

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Total dose of propofol administered to each patient

Outcome Description:

Analyzed using descriptive statistics and mixed model regression methods. Raw mean total dose administered and raw percentage of times additional propofol was administered will be presented by sedation group treating each event (sedation with lumbar puncture) as the unit. T-test and chi-square tests will be performed as appropriate.

Outcome Time Frame:

After each sedation

Safety Issue:

No

Principal Investigator

Dudley Hammon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 01211

NCT ID:

NCT01516684

Start Date:

January 2012

Completion Date:

Related Keywords:

  • Malignant Neoplasm
  • Neoplasms

Name

Location

Wake Forest University Health SciencesWinston-Salem, North Carolina  27157