Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

• 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 ]

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.

• 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

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