Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 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 31, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Malignant Neoplasm
Drug: placebo administration
Drug: EMLA
Drug: propofol
Drug: fentanyl citrate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
Drug: placebo administration
Given topically
Drug: propofol
Given IV
Other Name: Diprivan
Drug: fentanyl citrate
Given IV
Other Names:
  • Actiq
  • Oralet
  • Sublimaze

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  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: NCT01516684

Locations
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Dudley Hammon       dhammon@wakehealth.edu   
Principal Investigator: Dudley Hammon         
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Dudley Hammon Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT01516684     History of Changes
Other Study ID Numbers: CCCWFU 01211, NCI-2012-00019
Study First Received: January 20, 2012
Last Updated: July 31, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms
Anesthetics, Local
Prilocaine
Lidocaine
EMLA
Anesthetics
Fentanyl
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Anti-Arrhythmia Agents
Cardiovascular Agents
Hypnotics and Sedatives
Anesthetics, Combined

ClinicalTrials.gov processed this record on July 10, 2014