Ignite Creation Date:
2024-05-06 @ 12:12 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01516684
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2012-01-20
Brief Title:
Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Randomized Double Blind Trial of Pediatric Lumbar Puncture Under SedationTotal Intravenous Anesthesia TIVA With and Without EMLA Cream
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CCCWFU 01211 | OTHER | Wake Forest University Health Sciences | None |
| NCI-2012-00019 | REGISTRY | None | None |