A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous
试验速览
- 阶段
- 3 期
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- VAS for pain
研究概览
简要总结
The primary objective of this study is to investigate the Visual Analog Score (VAS) for pain within the post-operative setting and determine if there is a statistically significant difference between the VAS for PO or IV acetaminophen. It is expected that in doing so the investigators can produce the maximal amount of pain relief after surgery while making conscientious monetary decisions.
详细描述
Functional Endoscopic Sinus Surgery (FESS) is one of the most common Ear Nose and Throat Surgeries done in the United States annually. This procedure can vary from intense to moderate pain and as such it is difficult to properly gauge and treat postoperative pain in these patients. Commonly used in these cases, opioid drugs are given to provide adequate analgesia, however higher opioid usage is observed to cause increased Post-Anesthesia Care Unit (PACU) stays, respiratory complications and Postoperative Nausea and Vomiting (PONV). Acetaminophen is commonly used as an adjunct in these circumstances because of its opioid sparing properties.
Acetaminophen is a synthetic nonopioid p-aminophenol derivative available over the counter. Its properties include analgesic and antipyretic qualities and it is listed on the world health organization's list of essential medicines. The potential risks include liver damage, skin reactions and drug interactions when used with blood thinners at high doses. Acetaminophen has been extensively researched, in vitro and in vivo studies have found the drug to be safe when used at proper doses. Recently intravenous use of acetaminophen has gained popularity due to ease of use and ability to be given intraoperatively. This form of acetaminophen, although convenient, is around sixty two times the cost of oral acetaminophen. Due to this increased cost it is imperative that the investigators compare the two routes of administration in order to determine if the additional cost is justified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to participate
- •Undergoing FESS surgery at Massachusetts Eye and Ear (MEE)
- •Over the age of 18 during time of surgery
- •Weighing over 50kg
排除标准
- •Severe hepatic impairment or active liver disease
- •Known hypersensitivity to acetaminophen or to any excipients in the intravenous formulation
- •chronic opioid use
- •chronic pain
- •alcohol or drug abuse
研究组 & 干预措施
Acetaminophen 975mg Per Os
975mg of Acetaminophen given by mouth
干预措施: Acetaminophen (Drug)
Acetaminophen 1000mg Intravenous
1000mg of Acetaminophen given intravenously
干预措施: Acetaminophen (Drug)
结局指标
主要结局
VAS for pain
时间窗: 0-1 hour
First VAS pain score applied
次要结局
- Opioid Use(24 hours)
- Time in PACU(3-5 hours)
- VAS for pain(24 hours)
- PONV(24 hours)
研究者
Luliu Fat
Principal Investigator
Massachusetts Eye and Ear Infirmary
