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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
13
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.
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.
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.
St. Louis Children's Hospital
St Louis, Missouri, United States
Adequacy of Analgesia as Judged by Age-adjusted Pain Scales
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.
Time frame: 48 hour post-operative period
Quantity of Fentanyl Administered
Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.
Time frame: 48 hour post-operative period
Number of Participants With Respiratory Depression Within 48hrs Post op
Number of participants with respiratory depression within 48hrs post operation
Time frame: 48 hour post-operative period
Number of Participants With Hemodynamic Instability 48hrs Post op
Number of Participants with Hemodynamic Instability 48hrs post operation
Time frame: 48 hour post-operative period
Number of Participants With CSF Leaks Within 6 Months Post op.
Number of participants with CSF leaks within 6 months post operation.
Time frame: 6 month post-operative period
Number of Participants That Had Urine Retention for 48hrs Post Foley Catheter Removal.
Number of participants that had urine retention for 48hrs post foley catheter removal.
Time frame: After the Foley catheter has been removed on post-operative day #1 for a 48 hour follow-up period
Number of Participants With Nausea and/or Vomiting 48hrs Post op.
Number of participants with nausea and or vomiting 48hr post surgery
Time frame: 48 hour post-operative period
Number of Participants With Pruritis Within 48hrs Post op
Number of participants with pruritis within 48hrs post operation
Time frame: 48 hour post-operative period
Number of Participants That Were Given Codeine 48hr Post Surgery
Number of participants that were given codeine 48hr post surgery
Time frame: 48hr post surgery
Number of Participants That Were Given Zofran 48hr Post Surgery
Number of participants that were given Zofran 48hr post surgery
Time frame: 48hr post surgery
Number of Participants That Were Bradycardia Within 48hr Post Surgery
Number of participants that were bradycardia within 48hr post surgery
Time frame: 48hr post surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.