Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Comprehensive Cancer Center of Wake Forest University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT01516684
First received: January 20, 2012
Last updated: July 21, 2014
Last verified: July 2014

January 20, 2012
July 21, 2014
January 2012
January 2015   (final data collection date for primary outcome measure)
Total dose of propofol administered to each patient [ Time Frame: After each sedation ] [ Designated as safety issue: No ]
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.
Total dose of propofol administered to each patient [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01516684 on ClinicalTrials.gov Archive Site
  • Level of movement (no movement, minor movement, major movement, other) after EMLA cream or placebo cream administration [ Time Frame: At the time of LP insertion ] [ Designated as safety issue: No ]
  • Complications including any change in vital signs that requires intervention by the sedation team, as well as post-LP headache and post-LP back pain from sedation with or without EMLA cream [ Time Frame: Within one week of the LP ] [ Designated as safety issue: No ]
  • Traumatic lumbar punctures after EMLA cream or placebo cream administration [ Time Frame: After LP ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures
A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

This randomized clinical trial studies local anesthetic (EMLA) cream in younger patients undergoing lumbar punctures (LP). A local anesthetic cream may be effective for numbing the skin and reducing movement when applied prior to lumbar punctures and may reduce the amount of sedation necessary

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Malignant Neoplasm
  • Drug: placebo administration
    Given topically
  • Drug: EMLA
    Given topically
    Other Names:
    • eutectic mixture of local anesthetics
    • lidocaine-prilocaine
    • lidocaine-prilocaine eutectic mixture
  • Drug: propofol
    Given IV
    Other Name: Diprivan
  • Drug: fentanyl citrate
    Given IV
    Other Names:
    • Actiq
    • Oralet
    • Sublimaze
  • Experimental: Arm I (EMLA)
    Patients receive topical EMLA cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
    Interventions:
    • Drug: EMLA
    • Drug: propofol
    • Drug: fentanyl citrate
  • Active Comparator: Arm II (placebo)
    Patients receive topical placebo cream 60 minutes to 4 hours prior to the LP followed by standard sedation with fentanyl citrate and propofol.
    Interventions:
    • Drug: placebo administration
    • Drug: propofol
    • Drug: fentanyl citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
January 2015   (final data collection date for primary outcome measure)

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

Both
up to 22 Years
No
United States
 
NCT01516684
CCCWFU 01211, NCI-2012-00019
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Dudley Hammon Wake Forest School of Medicine
Comprehensive Cancer Center of Wake Forest University
July 2014

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