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临床试验/NCT01993589
NCT01993589已完成不适用

Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage

Kayseri Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2012年11月最近更新:
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
144
试验地点
1
主要终点
Pain

研究概览

简要总结

Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.

详细描述

A total of 144 mutiparous subjects randomly allocated one of six groups. The first group (control group) consisted of 22 participants and they did not receive any treatment. The second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.

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
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • multiparous participants
  • abnormal uterine bleeding
  • postmenopausal bleeding
  • myoma uteri causing menometrorrhagia
  • cervical polyp
  • tamoxifen treatment for breast cancer
  • adnexial mass

排除标准

  • abortions
  • pregnancy
  • primiparity
  • diabetes mellitus
  • tendency to bleed such as thrombocytopenia
  • factor deficiency
  • functional disorders of platelets

研究组 & 干预措施

Pain reliever

Active Comparator

1000 mg paracetamol (Parol 1 g Atabay ilaç Turkey)

干预措施: comparison of pain relievers during curattage (Drug)

pethidine

Active Comparator

Aldolan 100 mg Liba Laboratuarı İstanbul Turkey

干预措施: comparison of pain relievers during curattage (Drug)

Dexketoprofen trometamol

Active Comparator

25 mg oral Dexofen Atabay ilaç Turkey

干预措施: comparison of pain relievers (Drug)

Lidocaine spray

Active Comparator

2 puff on cervical mucosa (Xylocain Pump 100 Mg 50 Ml Sprey Astra Zeneca)

干预措施: comparison of pain relievers during curattage (Drug)

diclofenac sodium

Active Comparator

Dicloron amp 75 mg Deva İlaç Levent İstanbul/Turkey

干预措施: comparison of pain relievers during curattage (Drug)

结局指标

主要结局

Pain

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Kayseri Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Gökhan Açmaz

MD

Kayseri Education and Research Hospital

研究点 (1)

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