Ignite Creation Date:
2024-05-06 @ 12:25 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01576770
Status:
UNKNOWN
Last Update Posted:
2012-04-12
First Post:
2012-04-10
Brief Title:
In Children Does Using a Synera Patch Decrease Pain When Injecting Propofol at Anesthesia Induction
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
In Children Does the Use of Synera Patch for Local Analgesia Before Vascular Access Reduce Pain Associated With Propofol Injection for Anesthesia Induction
Status:
UNKNOWN
Status Verified Date:
2012-04
Last Known Status:
RECRUITING
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:
Synera patch
Brief Summary:
The purpose of this study is to evaluate if the Synera Patch lidocainetetracaine patch used to numb the skin before IV placement is effective in reducing pain associated with propofol IV administration when inducing general anesthesia compared to Gebauers Ethyl Chloride topical anesthetic skin refrigerant
Detailed Description:
Commonly anesthesiologists inject Propofol a sleeping medication intravenously to induce general anesthesia Propofol injection is associated with pain that can be severe
The investigators also place a lidocainetetracaine skin patch Synera to decrease pain associated with IV placement Because the local anesthetics of the Synera patch diffuse deep underneath the skin in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection
Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement A total of 33 patients will be enrolled in each group
The investigators also place a lidocainetetracaine skin patch Synera to decrease pain associated with IV placement Because the local anesthetics of the Synera patch diffuse deep underneath the skin in this study the investigators would like to evaluate whether the application of Synera Patch can decrease the pain associated with propofol injection
Children will be randomized to receive either the patch or the Ethyl Chloride before the IV placement A total of 33 patients will be enrolled in each group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None