Oxycodone vs. Fentanyl in the Treatment of Early Postoperative Pain After Total Hip Replacement
试验速览
- 阶段
- 4 期
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Postoperative pain measurement using Numeric Rating Scale(NRS)
研究概览
简要总结
Oxycodone is one of the most widely used opioids for pain treatment. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients after total hip replacement surgery.
详细描述
Oxycodone is one of the most widely used opioids for pain treatment. There have been several studies on the efficacy and side effects of oxycodone. Oxycodone has been known to have the same potency with morphine. Many studies demonstrated good efficacy of oxycodone on postoperative pain. In this study, we designed a prospective, randomized, and double-blind study to assess the efficacy and side effects of bolus intravenous of oxycodone injection compared to those of fentanyl in patients who underwent the total hip replacement surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19-65 years of age
- •ASA physical status classification I or II
- •Scheduled for total hip replacement surgery
排除标准
- •Allergic to study drugs
- •Patient with asthma or COPD, patient who is severely respiratory depressed
- •Renal of hepatic insufficiency
- •Epileptic status
- •Intracranial lesion associated with increased intracranial pressure
- •Acute abdomen, patient who has diagnosed paralytic ileus or suspicious ileus
- •Pregnant or lactating women
研究组 & 干预措施
Oxycodone
4mg of oxycodone iv bolus
干预措施: Oxycodone (Drug)
Fentanyl
50ug of fentanyl iv bolus
干预措施: Fentanyl (Drug)
结局指标
主要结局
Postoperative pain measurement using Numeric Rating Scale(NRS)
时间窗: Immediately after surgery
Measure postoperative pain using NRS at the PostAnesthesia Care Unit(PACU)
次要结局
- Additional doses of fentanyl for pain management(From immediately after surgery to 2 days after surgery)
研究者
Mi Kyeong Kim
Associate Professor
Kyunghee University Medical Center