Comparison of Low-dose Epidural With Intravenous Narcotic Versus Intravenous Narcotic Alone
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ClinicalTrials.gov Identifier: NCT00287326
Recruitment Status :
(terminated by PI)
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 or disease
Drug: Bupivacaine, Clonidine, Morphine
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).
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.
Study Start Date :
Actual Study Completion Date :
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Ages Eligible for Study:
4 Years to 16 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Elective lower extremity osteotomy
Expected length of stay greater than 24 hours
History of previous spine surgery
Current infection overlying catheter insertion site
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Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents