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临床试验/NCT04246541
NCT04246541已完成3 期

Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery

University Hospitals Cleveland Medical Center1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年4月23日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Pain Levels Recorded With a Visual Analogue Scale

研究概览

简要总结

The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.

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
None

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients between 18 and 89 years of age
  • Patients undergoing primary arthroscopic meniscus surgery

排除标准

  • Patients age less than 18 or greater than 89 years
  • Illiterate or non-English speaking patients
  • Patients with contraindications to ketorolac
  • History of drug or alcohol abuse
  • Chronic use of analgesic or psychotropic drugs

研究组 & 干预措施

Control

Experimental

Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery

干预措施: Oxycodone-Acetaminophen (Drug)

Ketorolac

Experimental

Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery.

干预措施: Ketorolac (Drug)

结局指标

主要结局

Pain Levels Recorded With a Visual Analogue Scale

时间窗: 2 weeks postoperatively

Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level.

Narcotic Medication Consumed

时间窗: up to 5 days postoperatively

Number of oxycodone- acetaminophen tablets consumed

次要结局

未报告次要终点

研究者

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

Michael Karns, MD.

Principal Investigator

University Hospitals Cleveland Medical Center

研究点 (1)

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