A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream
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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Total dose of propofol administered to each patient
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.
After each sedation
Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|