Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone

Tracking Information
First Submitted Date ICMJE	February 3, 2006
First Posted Date ICMJE	February 6, 2006
Last Update Posted Date	April 19, 2016
Study Start Date ICMJE	January 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: February 3, 2006)	24 hour recording of pain, sedation, narcotic usage, and satisfaction.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00287326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
Official Title ICMJE	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.
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 bupivacaine/clonidine epidural with supplemental narcotics to parenteral narcotics alone. Many studies substantiate the efficacy of bupivacaine and clonidine as effective drugs for epidural analgesia (1,2,3). 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 (5,6).
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Pain
Intervention ICMJE	Drug: Bupivacaine, Clonidine, Morphine
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Terminated
Estimated Enrollment ICMJE; (submitted: February 3, 2006)	40
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Age 4-16; English speaking; Elective lower extremity osteotomy; Expected length of stay greater than 24 hours Exclusion Criteria: History of previous spine surgery; Current infection overlying catheter insertion site; Coagulopathy
Sex/Gender	Sexes Eligible for Study: All
Ages	4 Years to 16 Years (Child)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00287326
Other Study ID Numbers ICMJE	05-Anes-231
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	University of North Carolina, Chapel Hill
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Michael J Stella, MD University of North Carolina, Chapel Hill
PRS Account	University of North Carolina, Chapel Hill
Verification Date	June 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP