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

Condition(s) targeted: Spastic Cerebral Palsy

Intervention: Extended-release Epidural morphine (EREM) 80 (Drug); Extended-release Epidural Morphine (EREM) 120 (Drug); Control: Saline (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Washington University School of Medicine

Official(s) and/or principal investigator(s):
David Limbrick, M.D., Ph.D., Principal Investigator, Affiliation: Washington University School of Medicine

Overall contact:
David D Limbrick, M.D., Ph.D., Phone: 314-454-2810, Email: limbrickd@nsurg.wustl.edu

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.

Official title: Randomized, Double-Blinded Placebo Controlled Trial of Epidural, Sustained-relief Morphine for Acute Post-operative Analgesia Following Selective Dorsal Rhizotomy in Children

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Quantity of fentanyl administered

Adequacy of analgesia as judged by age-adjusted pain scales.

Secondary outcome:

Incidence of respiratory depression

Hemodynamic instability

Rate of CSF leak

Rate of infection

Urinary retention

Nausea and/or vomiting

Pruritis

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Receiving selective dorsal rhizotomy (SDR)

- Willingness to Participate

Exclusion Criteria:

- Known Morphine Allergy

- Inability to speak and read the English language

David D Limbrick, M.D., Ph.D., Phone: 314-454-2810, Email: limbrickd@nsurg.wustl.edu

St. Louis Children's Hospital, St. Louis, Missouri 63110, United States

Related publications:

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Starting date: August 2009
Ending date: August 2013
Last updated: August 11, 2009