Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Oculoplastic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Pain 24 hours after recovery
研究概览
简要总结
The purpose of this study is to evaluate the postoperative pain and discomfort using flurbiprofen axetil or nalbuphine administration after oculoplastic surgery under general anesthesia.
详细描述
In this randomized controlled clinical trial, we evaluated the postoperative analgesic efficacy and adverse effects of flurbiprofen axetil combined with nalbuphine in patients undergoing oculoplastic surgery compared with a single dose of flurbiprofen axetil or nalbuphine.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing oculoplastic surgery
- •age between 16 and 75 years
- •American Society of Anesthesiologists (ASA) physical status of I-II
排除标准
- •serious coexisting disease
- •body mass index (BMI) <18.5 or >35
- •contraindications or previous adverse reactions to any of the drugs used
- •females with a positive pregnancy test
- •patients unable to cooperate
研究组 & 干预措施
flurbiprofen axetil
flurbiprofen axetil intraoperative administration 100mg
干预措施: Flurbiprofen Axetil (Drug)
nalbuphine
nalbuphine intraoperative administration 0.1mg/kg
干预措施: Nalbuphine (Drug)
nalbuphine and flurbiprofen axetil
flurbiprofen axetil intraoperative administration 100mg and nalbuphine intraoperative administration 0.1mg/kg
干预措施: Nalbuphine and Flurbiprofen Axetil (Drug)
结局指标
主要结局
Pain 24 hours after recovery
时间窗: 24 hours after recovery
Pain levels measured using Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable ; this scale has been confirmed to be sensitive and reliable.Clinically significant postoperative pain was considered serious pain (NRS score ≥5).
次要结局
- Discomfort 24 hours after recovery(24 hour after recovery)
研究者
Huijing Ye
Principal Investigator
Sun Yat-sen University