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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Information provided by: | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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).
Eligibility| Ages Eligible for Study: | 4 Years to 16 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Principal Investigator: | Michael J Stella, MD | University of North Carolina, Chapel Hill |
More Information
| ClinicalTrials.gov Identifier: | NCT00287326 History of Changes |
| Other Study ID Numbers: | 05-Anes-231 |
| Study First Received: | February 3, 2006 |
| Last Updated: | June 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Epidural Bupivacaine Clonidine |
|
Bupivacaine Clonidine Morphine Narcotics Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
Antihypertensive Agents Cardiovascular Agents Sympatholytics Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Analgesics, Opioid |