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Sponsored by: |
University of North Carolina |
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Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00287326 |
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 |
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Pain |
Drug: Bupivacaine, Clonidine, Morphine |
Phase III |
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. |
Estimated Enrollment: | 40 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | June 2006 |
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).
Ages Eligible for Study: | 4 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Michael J Stella, MD | The University of North Carolina, Chapel Hill |
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 |
Epidural Bupivacaine Clonidine |
Morphine Clonidine Bupivacaine Pain Pain, Postoperative |
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 |