跳至主要内容
临床试验/NCT02160236
NCT02160236Unknown4 期

Comparison of Postoperative Analgesic Efficacy of Intravenous Dexketoprofen Trometamol With Tenoxicam in Lumbar Disc Surgery

TC Erciyes University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
90
试验地点
1
主要终点
analgesic consumption

研究概览

简要总结

In this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

详细描述

Lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. Dexketoprofen has been reported to be one of the NSAİDs that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. Tenoxicam is a thienothiazine derivative of the oxicam class of NSAİDs. There are some studies in which NSAİDs have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

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

入选标准

  • between 18-65 age
  • elective lumbar disc surgery

排除标准

  • history of gastrointestinal bleeding
  • peptic ulcer disease
  • bleeding disorders
  • history of allergic reactions to NSAİDs
  • chronic pain syndrome

研究组 & 干预措施

dexketoprofen trometamol

Active Comparator

before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc

干预措施: dexketoprofen trometamol (Drug)

tenoxicam

Active Comparator

before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc

干预措施: tenoxicam (Drug)

serum physiologic

Placebo Comparator

before end of the surgery via administration intravenous 0.9 % NaCl 100 cc

干预措施: serum physiologic (Drug)

结局指标

主要结局

analgesic consumption

时间窗: postoperative 1 day

morphine consumption (patient control analgesia procedure) was recorded

次要结局

  • visual analog scale(postoperative 1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nazife Küçük

resident

TC Erciyes University

研究点 (1)

Loading locations...

相似试验