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Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children

NCT00955877

NAINTERVENTIONAL
Washington University School of Medicine
13 participants
Started 2010-03 · Completed 2015-01
Status: Terminated (as of 12-23-2025)

Conditions

Spastic Cerebral Palsy

Linked Papers (from SciSciNet-V2)

Total Papers19
Background
0
Result
0
Derived
0
Unknown
19

Total Citations Per Year

Brief Summary

The purpose of this proposal is to improve the investigators' current Selective Dorsal Rhizotomy (SDR) analgesia protocol by eliminating or minimizing the use of fentanyl in the post-operative period. Children undergoing SDR for spastic cerebral palsy have significant post-operative pain. The procedure requires dissection of the lumbar back musculature and removal of the L1 lamina (the bony posterior part of the vertebra). The majority of the operation is intradural, and a water-tight dural closure at the termination of the operation is critical in order to prevent leakage of cerebrospinal fluid (CSF) from the wound. In fact, these children must remain flat on their back for 48 hours to allow the dural incision to heal prior to mobilization. Thus, adequate pain control is essential not only for patient comfort, but also to prevent agitation and additional stress on the dural closure. Currently, the investigators' patients undergoing SDR are treated for 48 hours with scheduled intravenous (IV) narcotic (continuous fentanyl infusion at 0.5-2.0 μg/kg/hour) in addition to the sedative/muscle relaxant Valium (0.2 mg/kg IV every 4 hours for 24 hours, then every 6 hours for 24 hours). The IV fentanyl, and to a lesser degree Valium, carries a real risk of hypotension and respiratory depression and requires frequent dose adjustments to achieve adequate analgesia. By improving the current SDR analgesia protocol, the investigators hope to maximize patient safety and comfort while maintaining the effectiveness of the operation by minimizing the risk of CSF leak.

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Unknown Papers19

The FLACC: a behavioral scale for scoring postoperative pain in young children.
1997
1,534 citations
Temporal and demographic trends in cerebral palsy—Fact and fiction
2003
287 citations
Selective dorsal rhizotomy: meta-analysis of three randomized controlled trials
2002
274 citations
Correlates of improvement in multidisciplinary treatment of chronic pain.
1994
249 citations
A randomized clinical trial to compare selective posterior rhizotomy plus physiotherapy with physiotherapy alone in children with spastic diplegic cerebral palsy
1997
227 citations
Selective dorsal rhizotomy: efficacy and safety in an investigator‐masked randomized clinical trial
1998
221 citations
Evaluation of selective dorsal rhizotomy for the reduction of spasticity in cerebral palsy: a randomized controlled trial
1998
214 citations
Forty-eight Hours of Postoperative Pain Relief after Total Hip Arthroplasty with a Novel, Extended-Release Epidural Morphine Formulation
2005
139 citations
A Comparison of Depodur???, a Novel, Single-Dose Extended-Release Epidural Morphine, with Standard Epidural Morphine for Pain Relief After Lower Abdominal Surgery
2005
138 citations
Outcomes after selective dorsal rhizotomy for spastic cerebral palsy
2001
123 citations
The California Cerebral Palsy Project
1992
114 citations
Single-Dose, Sustained-Release Epidural Morphine in the Management of Postoperative Pain After Elective Cesarean Delivery: Results of a Multicenter Randomized Controlled Study
2005
111 citations
Surgical techniques of selective dorsal rhizotomy for spastic cerebral palsy. Technical note.
2006
106 citations
Selective dorsal rhizotomy and rates of orthopedic surgery in children with spastic cerebral palsy
1997
101 citations
Pain assessment in nonverbal children with severe cognitive impairments: the individualized numeric rating scale (INRS)
2003
95 citations
Single-Dose, Extended-Release Epidural Morphine (DepoDur™) Compared to Conventional Epidural Morphine for Post-Cesarean Pain
2007
85 citations
Evaluation of a Single-Dose, Extended-Release Epidural Morphine Formulation for Pain After Knee Arthroplasty
2006
71 citations
Extended-release epidural morphine (DepoDur™): review and safety analysis
2008
48 citations
Single-dose extended-release epidural morphine for pain after hip arthroplasty
2006
16 citations