Acetaminophen vs Placebo in the Pre-operative Setting and Outcomes on Post-operative Pain, Nausea and Vomiting (IV)
A Double-blind Randomized, Placebo-controlled Study to Determine the Effectiveness of Pre-operative IV Acetaminophen Administration in Reducing Post-operative Pain, Nausea, and Vomiting in the Outpatient Setting
研究概览
详细说明
The purpose of this study is to determine if using a one time pre-operative dose of IV acetaminophen has an effect on post-operative nausea, vomiting, and pain. This is a randomized, double-blind, placebo-controlled prospective study on patients from the Katzmann Breast Center undergoing outpatient breast surgery (including excisional biopsy, lumpectomy, sentinel lymph node biopsy, axillary node dissection, or ductal excision).
IV acetaminophen (paracetamol) has been in Europe and other countries. In the U.S. the FDA approved IV acetaminophen (Ofirmev) in November of 2010. Since then, it has been used in many different ways, but most commonly in the first 24 hours post operative recovery period.
There will be two arms included in this study. Patients in Arm One will receive a one gram dose of IV acetaminophen in the pre-operative area. Patients in Arm Two will receive a dose of the placebo (IV normal saline). The medication will be disguised in the same bag as the normal saline, so no one (including the patient) in the pre-operative area will know which arm the patient is in. This prospective, randomized, double blind study will compare post-operative nausea, vomiting, and pain rates in patients from both arms.
The primary endpoint of this study will be to compare post-operative pain in patients receiving a pre-operative dose of IV acetaminophen to patients receiving the normal saline placebo. Secondary endpoints will include post-operative nausea and vomiting, recovery times, and overall satisfaction of pain management throughout their experience (assessed on post operative day one). If this study shows that IV acetaminophen given in the pre-operative setting decreases post-operative nausea, vomiting, and/or pain and/or shortens recovery time, and improves patient satisfaction in regards to their pain management, it could also become a routine medication given to all patients in the pre-operative setting.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Iowa
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Des Moines、Iowa、美国、50314
- Mercy Medical Center-Des Moines
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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:
Each of the following must be met:
- Greater than or equal to 18 years of age.
- Female
- Undergoing outpatient breast surgery (unilateral or bilateral surgery)
Exclusion Criteria:
If ANY of the following apply:
- History of an allergy or hypersensitivity to acetaminophen (oral, rectal, or IV)
- Chronic alcoholism
- Severe deficiency of liver and/or kidney
- Any patient unable to sign informed consent
- Pregnancy
- Any patient currently enrolled in another experimental protocol
学习计划
研究是如何设计的？
设计细节
- 主要用途：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 |
|---|---|
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有源比较器：IV acetaminophen
Patients in the IV acetaminophen arm will receive a one gram dose of IV acetaminophen in the pre-operative area prior to their surgery.
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Single dose of one gram of IV acetaminophen given in pre-operative area
其他名称：
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安慰剂比较：Placebo
Patients in the placebo arm will receive normal saline in the pre-operative area.
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placebo (IV normal saline)
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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 |
|---|---|---|
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postoperative pain
大体时间：first postoperative day
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postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting
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first postoperative day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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postoperative nausea and vomiting (PONV)
大体时间：first postoperative day
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patient-rated postoperative nausea and vomiting (PONV) on visual analog scale
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first postoperative day
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time until readiness of discharge
大体时间：first postoperative day
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time until readiness of discharge: measured from arrival to the recover room to discharge-order-written time (DOW time)
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first postoperative day
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IV analgesic consumption in recovery room
大体时间：first postoperative day
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intravenous analgesic consumption in recovery room: converted to morphine-equivalents
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first postoperative day
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合作者和调查者
调查人员
- 首席研究员：Lauren D Allan, DO、Mercy Medical Center-Des Moines General Surgery Residency
研究记录日期
研究主要日期
学习开始
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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