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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- postoperative pain
研究概览
简要总结
The purpose of this study is to determine whether a single dose of IV acetaminophen can improve post-operative pain, nausea, and vomiting in the outpatient setting. Patient satisfaction, time to readiness of discharge, and the amount of opiates post operatively will also be measured.
详细描述
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Each of the following must be met:
- •Greater than or equal to 18 years of age.
- •Undergoing outpatient breast surgery (unilateral or bilateral surgery)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: IV acetaminophen (Drug)
Placebo
Patients in the placebo arm will receive normal saline in the pre-operative area.
干预措施: placebo (Drug)
结局指标
主要结局
postoperative pain
时间窗: first postoperative day
postoperative pain as measured by visual analog scale (VAS, range 0-10) measured in recovery room before discharge to outpatient setting
次要结局
- postoperative nausea and vomiting (PONV)(first postoperative day)
- time until readiness of discharge(first postoperative day)
- IV analgesic consumption in recovery room(first postoperative day)