跳至主要内容
临床试验/NCT00955877
NCT00955877终止不适用

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

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
13
试验地点
1
主要终点
Adequacy of Analgesia as Judged by Age-adjusted Pain Scales

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Receiving selective dorsal rhizotomy (SDR)
  • Willingness to Participate

排除标准

  • Known Morphine Allergy
  • Inability to speak and read the English language

研究组 & 干预措施

DepoDur80

Experimental

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.

干预措施: Extended-release Epidural morphine (EREM) 80 (Drug)

DepoDur120

Experimental

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.

干预措施: Extended-release Epidural Morphine (EREM) 120 (Drug)

结局指标

主要结局

Adequacy of Analgesia as Judged by Age-adjusted Pain Scales

时间窗: 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

时间窗: 48 hour post-operative period

Mean and standard deviation of total quantity of fentanyl administered (per patient per day) 48hrs post surgery.

次要结局

  • Number of Participants With Respiratory Depression Within 48hrs Post op(48 hour post-operative period)
  • Number of Participants With Hemodynamic Instability 48hrs Post op(48 hour post-operative period)
  • Number of Participants With CSF Leaks Within 6 Months Post op.(6 month post-operative period)
  • 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 With Nausea and/or Vomiting 48hrs Post op.(48 hour post-operative period)
  • Number of Participants That Were Given Codeine 48hr Post Surgery(48hr post surgery)
  • Number of Participants That Were Given Zofran 48hr Post Surgery(48hr post surgery)
  • Number of Participants That Were Bradycardia Within 48hr Post Surgery(48hr post surgery)
  • Number of Participants With Pruritis Within 48hrs Post op(48 hour post-operative period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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