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临床试验/NCT03295214
NCT03295214Unknown3 期

A Prospective Clinical Trial Evaluating the Post-Operative Analgesic Effects of Acetaminophen Given Per Os and Intravenous

Massachusetts Eye and Ear Infirmary1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2018年3月28日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

975mg of Acetaminophen given by mouth

干预措施: Acetaminophen (Drug)

Acetaminophen 1000mg Intravenous

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luliu Fat

Principal Investigator

Massachusetts Eye and Ear Infirmary

研究点 (1)

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