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Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

This study has suspended participant recruitment.
(Resource Issues)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516684
First Posted: January 25, 2012
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 Phase
Malignant Neoplasm Drug: placebo administration Drug: EMLA Drug: propofol Drug: fentanyl citrate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Total dose of propofol administered to each patient [ Time Frame: After each sedation ]
    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 ]
  • 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 ]
  • Traumatic lumbar punctures after EMLA cream or placebo cream administration [ Time Frame: After LP ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516684


Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Dudley Hammon Wake Forest University Health Sciences
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01516684     History of Changes
Other Study ID Numbers: CCCWFU 01211
NCI-2012-00019 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: January 20, 2012
First Posted: January 25, 2012
Last Update Posted: May 30, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms
Lidocaine
Anesthetics, Local
Prilocaine
EMLA
Propofol
Anesthetics
Fentanyl
Citric Acid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Anesthetics, Combined