The Efficacy of Continuous Intravenous Ketorolac for Postoperative Pain in Laparoscopic Donor Nephrectomy: a Double Blinded Randomized Placebo Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Pain 'Right Now'
研究概览
简要总结
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having laparoscopic surgery to donate a kidney.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients donating a kidney via laparoscopic donor nephrectomy
排除标准
- •History of NSAID allergy
- •History of long term opioid use
- •Intraoperative blood loss greater than 300 mL
- •Postoperative hemodynamic instability
- •Active peptic ulcer disease
- •Advanced renal impairment (Cr > 2.0 mg/dL)
- •Bleeding diathesis
- •Current use of probenecid
- •Pregnancy
研究组 & 干预措施
Ketorolac
90 mg ketorolac in 1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
干预措施: Ketorolac (Drug)
Placebo
1 L of normal saline infused at 40-120 mL/hr for 18.5-23 hours beginning 0.5 hours after the end of surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain 'Right Now'
时间窗: 24 hours after the end of surgery
Visual analog scale score for pain on a scale from 0 = None to 10 = Worst.
Morphine Equivalents of Concomitant Pain Medication
时间窗: 24 hours after the end of surgery
The morphine equivalent is a unit of measure to compare the efficacy of different types of opioids (narcotics). The patients were allowed to take additional pain medication in addition to either study drug or placebo. This outcome measure reports the amount of morphine (in mg) equivalent to the amount of concomitant pain medication used by the patient.
次要结局
未报告次要终点