Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Hours Until Tolerating Oral Intake
研究概览
简要总结
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.
详细描述
Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic scoliosis requiring spine fusion surgery
- •Age 10-21 years
排除标准
- •Inability to understand PCA instructions
- •Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
- •Chronic opioid therapy > 2 months
- •Non-English speaking
研究组 & 干预措施
Naloxone infusion 0.5 mcg/kg/hr
干预措施: Naloxone (Drug)
Naloxone 2.5 mcg/kg/hr
Naloxone infusion 2.5 mcg/kg/hr
干预措施: Naloxone (Drug)
结局指标
主要结局
Number of Hours Until Tolerating Oral Intake
时间窗: Assessed daily in hospital while in hospital until taking orals, average 4 days.
Defined as time when awakening after surgery until tolerating orals.
次要结局
- Severity of Itching(Assessed daily while in hospital requiring PCA)
- Severity of Nausea(Assessed daily while in hospital requiring PCA.)
- Severity of Pain(Assessed by bedside nurse 3 times daily while requiring PCA)
研究者
Ben J Pieters
Staff Anesthesiologist
Children's Mercy Hospital Kansas City