Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures

Study Overview
=================
Brief Summary
-----------------
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

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.

Official Title
-----------------
A Randomized, Double Blind Trial of Pediatric Lumbar Puncture Under Sedation/Total Intravenous Anesthesia (TIVA) With and Without EMLA Cream

Conditions
-----------------
Malignant Neoplasm

Intervention / Treatment
-----------------
* Drug: placebo administration
* Drug: EMLA
* Drug: propofol
* Drug: fentanyl citrate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Maximum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (EMLA)<br>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<br>* Given topically<br>* Other names: lidocaine-prilocaine eutectic mixture;Drug: propofol<br>* Given IV<br>* Other names: Diprivan;Drug: fentanyl citrate<br>* Given IV<br>* Other names: Sublimaze;|
| Active Comparator: Arm II (placebo)<br>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<br>* Given topically<br>Drug: propofol<br>* Given IV<br>* Other names: Diprivan;Drug: fentanyl citrate<br>* Given IV<br>* Other names: Sublimaze;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20 minutes after sedation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Movement (no Movement, Minor Movement, Major Movement, Other) After EMLA Cream or Placebo Cream Administration |  | 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 From Sedation With or Without EMLA Cream | Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any headache after the lumbar puncture, and if they had any other complications. | Within one week of the LP | 
| Traumatic Lumbar Punctures After EMLA Cream or Placebo Cream Administration | Traumatic lumbar puncture is defined as lumbar puncture in which cerebrospinal fluid contains at least 10 red blood cells (RBCs) per microliter and bloody lumbar as one in which the cerebrospinal fluid contained at least 500 red blood cells (RBCs) per microliter. | 20 minutes after lumbar puncture | 
| Complications Including Any Change in Vital Signs That Requires Intervention by the Sedation Team, Post-LP Back Pain From Sedation With or Without EMLA Cream | Each patient's parent (and/or the patient) will be contacted by telephone within one week of the lumbar puncture (or in person if the next clinic visit is within one week) to ask if the patient had any back pain after the lumbar puncture, and if they had any other complications. | Within one week of the LP |