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临床试验/NCT02602197
NCT02602197Unknown3 期

The Efficacy of Intravenous Paracetamol Versus Dexketoprofen for Postoperative Pain Management After Septoplasty: A Prospective Randomized Double Blind Study

Baskent University0 个研究点目标入组 2 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
2
主要终点
Change from pain scores until postoperative 24 hours

研究概览

简要总结

The investigators conducted a prospective, randomized, double blind study to compare the effectiveness of intravenous paracetamol and dexketoprofen for preventing pain during first 24 hours postoperative period in adult patient undergoing septoplasty.

详细描述

Postoperative pain scores as measured by Visual Analog Scale (VAS) (0 represented no pain and 10 the worst pain ever experienced) at 15, 30, 60 minutes and 2th, 4th, 6th, 12th and 24th hours postoperatively.

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
Double (Participant, Investigator)

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

  • After patient's inform consent was approved, a total of 70 ASA (American Society of Anesthesiology) physical status I and II adult patients age 18 to 65 undergoing septoplasty were planned include the study.

排除标准

  • History of clotting disorders or blood dyscrasias,
  • Gastrointestinal ulcer or chronic dyspepsia,
  • History of allergy to the study drugs,
  • Active bleeding or bleeding disorders.

研究组 & 干预措施

Paracetamol

Active Comparator

1 gr paracetamol received intravenously bolus 15 minutes after anesthetic induction and at the postoperative 6 th,12 th, 18 th and 24 th hours

干预措施: Paracetamol (Drug)

Dexketoprofen

Active Comparator

50 mg dexketoprofen received intravenous bolus 15 minutes after anesthetic induction and at the postoperative 8 th,16 th and 24 th hours.

干预措施: Dexketoprofen (Drug)

结局指标

主要结局

Change from pain scores until postoperative 24 hours

时间窗: Pain scores recorded during postoperative 24 hours.

Pain scores as measured by Visual Analog Scale (VAS) at 15 and 30 minutes, 1h, 2h, 4h, 6h, 12h, and 24 h after surgery

次要结局

  • Cumulative tramadol consumption during postoperative 24 hours.(First postoperative 24 hours)

研究者

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

Esra Caliskan

Associated Professor

Baskent University

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