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

Not Applicable

Terminated

Conditions: Spastic Cerebral Palsy

Interventions: Drug: Extended-release Epidural morphine (EREM) 80
Drug: Extended-release Epidural Morphine (EREM) 120

Registration Number: NCT00955877

Lead Sponsor: Washington University School of Medicine

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 13

Inclusion Criteria

Receiving selective dorsal rhizotomy (SDR)
Willingness to Participate

Exclusion Criteria

Known Morphine Allergy
Inability to speak and read the English language

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DepoDur80	Extended-release Epidural morphine (EREM) 80	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.
DepoDur120	Extended-release Epidural Morphine (EREM) 120	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.

Primary Outcome Measures

Name	Time	Method
Adequacy of Analgesia as Judged by Age-adjusted Pain Scales	48 hour post-operative period	Mean and standard deviation for standardized, age-appropriate pain scales (per patient per day) 48hrs post surgery. As is standard of care at St. Louis Children's Hospital, pain level was scored based on age using the "Face, Legs, Activity, Cry, Consolability" (FLACC) for participants aged 0-3, the FACES scale on participants between the age of 3 and 5, numeric pain rating scale (NRS) on participants between the age of 5 and 8 years, or the Individualized Numeric Rating Scale (INRS) for participants greater than or equal to 8 years of age. All four of the scales were ranged from 0-10 scores, with 0 being no pain at all, and 10 being extreme pain. Each patient had two scores given, one at 24hrs and one at 48hrs post surgery. The output was reported as an average of all scores for all patients within each group.
Quantity of Fentanyl Administered	48 hour post-operative period	Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Respiratory Depression Within 48hrs Post op	48 hour post-operative period	Number of participants with respiratory depression within 48hrs post operation
Number of Participants With Hemodynamic Instability 48hrs Post op	48 hour post-operative period	Number of Participants with Hemodynamic Instability 48hrs post operation
Number of Participants With CSF Leaks Within 6 Months Post op.	6 month post-operative period	Number of participants with CSF leaks within 6 months post operation.
Number of Participants That Had Urine Retention for 48hrs Post Foley Catheter Removal.	After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period	Number of participants that had urine retention for 48hrs post foley catheter removal.
Number of Participants With Nausea and/or Vomiting 48hrs Post op.	48 hour post-operative period	Number of participants with nausea and or vomiting 48hr post surgery
Number of Participants That Were Given Codeine 48hr Post Surgery	48hr post surgery	Number of participants that were given codeine 48hr post surgery
Number of Participants That Were Given Zofran 48hr Post Surgery	48hr post surgery	Number of participants that were given Zofran 48hr post surgery
Number of Participants That Were Bradycardia Within 48hr Post Surgery	48hr post surgery	Number of participants that were bradycardia within 48hr post surgery
Number of Participants With Pruritis Within 48hrs Post op	48 hour post-operative period	Number of participants with pruritis within 48hrs post operation