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临床试验/NCT03562611
NCT03562611已完成不适用

Flurbiprofen Axetil and Nalbuphine for Postoperative Pain and Discomfort After Orbital Decompression

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2018年6月8日最近更新:
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
发起方
入组人数
63
试验地点
1
主要终点
Pain after orbital decompression

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 orbital decompression under general anesthesia.

详细描述

To investigate postoperative analgesia achieved with intraoperative administration of intravenous nalbuphine and flurbiprofen axetil in patients undergoing orbital decompression

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

入选标准

  • 16-75 years old
  • diagnosed as thyroid eye disease
  • bone removal orbital decompression under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status of I-II

排除标准

  • body mass index (BMI) <18.5 or >35
  • any uncontrolled clinical problems

研究组 & 干预措施

flurbiprofen axetil

Active Comparator

flurbiprofen axetil intraoperative administration 100mg

干预措施: Flurbiprofen Axetil (Drug)

nalbuphine

Experimental

nalbuphine intraoperative administration 0.1mg/kg

干预措施: Nalbuphine (Drug)

nalbuphine and flurbiprofen axetil

Experimental

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 after orbital decompression

时间窗: 24 hour 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 after orbital decompression(24 hour after recovery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huijing Ye

Principal Investigator

Sun Yat-sen University

研究点 (1)

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