Extended-release Epidural Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Spastic Cerebral Palsy |
Drug: Extended-release Epidural morphine (EREM) 80 Drug: Extended-release Epidural Morphine (EREM) 120 Drug: Control: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blinded Placebo Controlled Trial of Epidural, Sustained-relief Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children |
- Quantity of fentanyl administered [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: No ]
- Adequacy of analgesia as judged by age-adjusted pain scales. [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: No ]
- Incidence of respiratory depression [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: Yes ]
- Hemodynamic instability [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: Yes ]
- Rate of CSF leak [ Time Frame: 6 month post-operative period ] [ Designated as safety issue: Yes ]
- Rate of infection [ Time Frame: 6 month post-operative period ] [ Designated as safety issue: Yes ]
- Urinary retention [ Time Frame: After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period ] [ Designated as safety issue: Yes ]
- Nausea and/or vomiting [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: Yes ]
- Pruritis [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 147 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DepoDur80
DepoDur will be administered at 80μg/kg (not to exceed 5 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.
|
Drug: Extended-release Epidural morphine (EREM) 80
After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (80μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
Other Name: DepoDur
|
|
Experimental: DepoDur120
DepoDur will be administered at 120μg/kg (not to exceed 10 mg total/patient) under direct vision in the L1 laminectomy defect prior to wound closure.
|
Drug: Extended-release Epidural Morphine (EREM) 120
After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Epidural DepoDur (120μg/kg) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
Other Name: DepoDur
|
|
Placebo Comparator: Control
Preservative-free normal saline (2.5ml) will be placed in the L1 laminectomy defect and also dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter prior to wound closure.
|
Drug: Control: Saline
After completion of the rhizotomy, the dura will be closed in the standard water-tight fashion with running suture. Preservative-free normal saline (2.5 ml) will be placed under direct vision in the L1 laminectomy defect. It will also be dispensed 1-2 levels above and 1-2 levels below using a flexible angiocatheter.
|
Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Receiving selective dorsal rhizotomy (SDR)
- Willingness to Participate
Exclusion Criteria:
- Known Morphine Allergy
- Inability to speak and read the English language
Contacts and Locations| Contact: David D Limbrick, M.D., Ph.D. | 314-454-2810 | limbrickd@nsurg.wustl.edu |
| Contact: Micheal Lehmkuhl, R.N. | 314-454-5499 | lehmkuhlm@wudosis.wustl.edu |
| United States, Missouri | |
| St. Louis Children's Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: David Limbrick, M.D., Ph.D. 314-454-2810 limbrickd@nsurg.wustl.edu | |
| Contact: Micheal Lehmkuhl, R.N. 314-454-5499 lehmkuhlm@wudosis.wustl.edu | |
| Principal Investigator: David Limbrick, M.D., Ph.D. | |
| Principal Investigator: | David Limbrick, M.D., Ph.D. | Washington University School of Medicine |
More Information
Publications:
| Responsible Party: | David Limbrick, Washington University |
| ClinicalTrials.gov Identifier: | NCT00955877 History of Changes |
| Other Study ID Numbers: | DeporDur2009 |
| Study First Received: | August 3, 2009 |
| Last Updated: | August 3, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Washington University School of Medicine:
|
extended-release epidural morphine DepoDur Spastic Cerebral Palsy |
Additional relevant MeSH terms:
|
Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Morphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics |
ClinicalTrials.gov processed this record on May 19, 2013