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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00955877
First received: August 3, 2009
Last updated: January 22, 2015
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Adequacy of analgesia as judged by age-adjusted pain scales and Quantity of fentanyl administered . [ Time Frame: 48 hour post-operative period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: March 2010
Study Completion Date: January 2015
Primary Completion Date: January 2015 (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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955877

Locations
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: David Limbrick, M.D., Ph.D. Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00955877     History of Changes
Other Study ID Numbers: DeporDur2009 
Study First Received: August 3, 2009
Last Updated: January 22, 2015
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
Muscle Spasticity
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on December 02, 2016