Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00287326
Status:
TERMINATED
Last Update Posted:
2016-04-19
First Post:
2006-02-03
Brief Title:
Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Comparison of Epidural Bupivacaine-Clonidine With Intravenous Morphine Versus Intravenous Morphine Alone for Post-Operative Pain Relief in Pediatric Patients Undergoing Lower Extremity or Pelvic Osteotomy
Status:
TERMINATED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated by PI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to determine if a low-dose epidural drug mixture without narcotic will result in lower parenteral narcotic usage and improved side-effect profile for post-operative pain in the pediatric population undergoing lower extremity or pelvic osteotomy
Detailed Description:
Post-operative pain in patients undergoing osteotomy can be severe Current methods of treatment involve parenteral narcotics and regional anesthesia Several studies have looked at the efficacy of regional anesthesia with various combinations of local anesthetic and additives in different populations However to our knowledge there have been none that directly compare bupivacaineclonidine epidural with supplemental narcotics to parenteral narcotics alone Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia 123 Parenteral narcotic alone is associated with the possibility of significant side effects overdose and inadequate analgesia Epidural analgesia has been shown to reduce postoperative pain scores more than parenteral narcotics 4 We believe that this study is important since the protocol allows additional parenteral narcotic in the epidural group if needed and also allows for narcotic dosing prior to discontinuation of the epidural to compensate for rebound pain Further the prolongation of pain control shown with epidural clonidine may be beneficial during the transition 56
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