Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Missouri
-
Kansas City、Missouri、美国、64108
- Children's Mercy Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Idiopathic scoliosis requiring spine fusion surgery
- Age 10-21 years
Exclusion Criteria:
- Inability to understand PCA instructions
- Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
- Chronic opioid therapy > 2 months
- Non-English speaking
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Naloxone infusion 0.5 mcg/kg/hr
|
Naloxone infusion 0.5 mcg/kg/hr
其他名称：
Naloxone infusion 2.5 mcg/kg/hr
其他名称：
|
|
实验性的：Naloxone 2.5 mcg/kg/hr
Naloxone infusion 2.5 mcg/kg/hr
|
Naloxone infusion 0.5 mcg/kg/hr
其他名称：
Naloxone infusion 2.5 mcg/kg/hr
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Hours Until Tolerating Oral Intake
大体时间：Assessed daily in hospital while in hospital until taking orals, average 4 days.
|
Defined as time when awakening after surgery until tolerating orals.
|
Assessed daily in hospital while in hospital until taking orals, average 4 days.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Severity of Itching
大体时间：Assessed daily while in hospital requiring PCA
|
Visual analog scale presented to subject to complete daily. Minimum value 0 "none" to maximum value 10 "worst possible". Higher scores represent worse outcome. Title of scale "Itching VAS". Scores were assessed daily for 5 days and an average of the five days was reported. |
Assessed daily while in hospital requiring PCA
|
|
Severity of Nausea
大体时间：Assessed daily while in hospital requiring PCA.
|
Nausea VAS presented to subject daily. Zero minimum "none" to 10 maximum "worse possible". Higher scores represent worse clinical outcome. Name of scale "Nausea VAS". Scores were assessed daily for 5 days and an average of the five days reported. |
Assessed daily while in hospital requiring PCA.
|
|
Severity of Pain
大体时间：Assessed by bedside nurse 3 times daily while requiring PCA
|
Visual analog scale for pain. Zero "none" minimum to 10 "worse possible" maximum. Name of scale "Pain VAS". Scores were assessed daily for 5 days and an average of the five days was reported. |
Assessed by bedside nurse 3 times daily while requiring PCA
|
合作者和调查者
调查人员
- 首席研究员：Benjamin J. Pieters, DO、Children's Mercy Hospital Kansas City
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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