Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

Wake Forest University (WFU)

Status and phase: Completed; Phase 2

Conditions: Malignant Neoplasm

Treatments: Drug: placebo administration; Drug: propofol; Drug: EMLA; Drug: fentanyl citrate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01516684

NCI-2012-00019 (Registry Identifier)

IRB00017079

CCCWFU 01211 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: Under 22 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Arm I (EMLA)

Experimental group

Description:

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

Treatment:

Drug: fentanyl citrate

Drug: EMLA

Drug: propofol

Arm II (placebo)

Active Comparator group

Description:

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

Treatment:

Drug: placebo administration

Drug: fentanyl citrate

Drug: propofol