Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures
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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 |
|---|---|
|
Malignant Neoplasm |
Drug: placebo administration Drug: EMLA Drug: propofol Drug: fentanyl citrate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- Total dose of propofol administered to each patient [ Time Frame: After each sedation ] [ Designated as safety issue: No ]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.
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | January 2015 (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:
Drug: propofol
Given IV
Other Name: Diprivan
Drug: fentanyl citrate
Given IV
Other Names:
|
|
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:
|
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| Ages Eligible for Study: | up to 22 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Dudley Hammon dhammon@wakehealth.edu | |
| Principal Investigator: Dudley Hammon | |
| Principal Investigator: | Dudley Hammon | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01516684 History of Changes |
| Other Study ID Numbers: | CCCWFU 01211, NCI-2012-00019 |
| Study First Received: | January 20, 2012 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms Anesthetics, Local Prilocaine Lidocaine EMLA Anesthetics Fentanyl Propofol Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Narcotics Analgesics Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid Anti-Arrhythmia Agents Cardiovascular Agents Hypnotics and Sedatives Anesthetics, Combined |
ClinicalTrials.gov processed this record on May 23, 2013