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Comparison of Low-Dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
This study is currently recruiting participants.
Verified by The University of North Carolina, Chapel Hill, June 2005
Sponsored by: University of North Carolina
Information provided by: The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00287326
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Bupivacaine, Clonidine, Morphine
Phase III

Drug Information available for: Clonidine Clonidine hydrochloride Bupivacaine Bupivacaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 24 hour recording of pain, sedation, narcotic usage, and satisfaction.

Estimated Enrollment: 40
Study Start Date: January 2006
Estimated Study Completion Date: June 2006
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).

  Eligibility

Ages Eligible for Study:   4 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287326

Locations
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Barbara Longmire     919-843-2698     oct@unc.edu    
Sub-Investigator: Robert Valley, MD            
Sub-Investigator: Justin Hauser, MD            
Sub-Investigator: Victoria Salo-Coombs, RN            
Sub-Investigator: Carl Schuler, RN            
Sponsors and Collaborators
University of North Carolina
Investigators
Principal Investigator: Michael J Stella, MD The University of North Carolina, Chapel Hill
  More Information

Study ID Numbers: 05-Anes-231
Study First Received: February 3, 2006
Last Updated: February 27, 2006
ClinicalTrials.gov Identifier: NCT00287326  
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of North Carolina, Chapel Hill:
Epidural
Bupivacaine
Clonidine

Study placed in the following topic categories:
Morphine
Clonidine
Bupivacaine
Pain
Pain, Postoperative

Additional relevant MeSH terms:
Sympatholytics
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Cardiovascular Agents
Antihypertensive Agents
Anesthetics, Local
Pharmacologic Actions
Adrenergic Agonists
Autonomic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009