跳至主要内容
临床试验/NCT02181426
NCT02181426已完成不适用

Dose Response of Ketorolac in Out-Patients Undergoing Knee Arthroscopy

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
1
主要终点
PACU Opiate Consumption

研究概览

简要总结

Ketorolac is administered as current practice to the majority of patients undergoing knee arthroscopy, the appropriate dose of ketorolac to be administered has not been evaluated.

详细描述

Past studies have examined different doses of ketorolac administered to patients after spinal fusion surgery and found that 7.5 mg every 6 hours was as effective as 15 or 30 mg every 6 hours in decreasing postoperative pain and patient opiate consumption. Since ketorolac side effects such as gastrointestinal and surgical site bleeding seem to be dose related, utilizing a lower dose of ketorolac may be more efficacious.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to consent and desire to participate in study
  • Outpatient knee arthroscopy with Dr. C. David Geier
  • ASA physical status I-III
  • 18-65 years old
  • Over 50 kg (110 pounds)
  • General anesthesia
  • Exclusion Criteria
  • Any contraindication to receiving a non-steroidal antiinflammatory medication (including but not limited to allergy to any non-steroidal antiinflammatory medications including aspirin; chronic renal insufficiency; history of gastric ulcers, gastritis, peptic ulcers or gastrointestinal bleeding; severe volume depletion; presence of cerebrovascular bleeding or high risk of bleeding)
  • Allergy to propofol, fentanyl or hydromorphone.
  • Any chronic painful conditions requiring opioid use for over the last 6 months
  • Emergency surgery
  • Altered mental status (not oriented to place, person or time)
  • Pregnant or lactating patients
  • Patient is taking non-steroidal antiinflammatory medications (including aspirin)1 at home and took that medication on day of surgery.
  • Non-English speaking
  • Patient refusal to study
  • Patient refusal or not a candidate for general anesthesia with Laryngeal Mask Airway (LMA)

排除标准

  • 未提供

研究组 & 干预措施

0 mg of Ketorolac

Placebo Comparator

participant receives 0 mg of Ketorolac

干预措施: Ketorolac Dose (Drug)

7.5 mg of Ketorolac

Active Comparator

participant receives 7.5 mg of Ketorolac

干预措施: Ketorolac Dose (Drug)

15 mg Ketorolac

Active Comparator

participant receives 15 mg of Ketorolac

干预措施: Ketorolac Dose (Drug)

30 mg Ketorolac

Active Comparator

participant receives 30mg of Ketorolac

干预措施: Ketorolac Dose (Drug)

结局指标

主要结局

PACU Opiate Consumption

时间窗: Less than 1 day (PACU stay in the postoperative period)

Total PACU opioid consumption measured in intravenous morphine mg equivalents (IV MME).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验