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临床试验/NCT02428777
NCT02428777Unknown3 期

Tramadol Versus Diclofenac for Prevention of Pain in Operative Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial

Cairo University2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2015年4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
210
试验地点
2
主要终点
Pain during the procedure as measured by the visual analogue scale

研究概览

简要总结

The purpose of this study is to compare the effectiveness of Tramadol and diclofenac in reducing pain during operative outpatient hysteroscopy. Women undergoing operative hysteroscopy will be divided into 3 groups, the first group will receive Tramadol 100 mg 1 hour before the procedure, the second group will receive diclofenac 100mg 1 hour before the procedure and the third will receive a placebo. Pain will be assessed by a visual analogue scale

详细描述

Hysteroscopic examination is currently the most informative investigation for patients with abnormal uterine bleeding and infertility. Outpatient hysteroscopy involves the use of miniaturized endoscopic equipment to directly visualise the endometrial cavity, without the need of formal theatre facilities, general or regional anaesthesia.

Outpatient hysteroscopy is increasingly being used as a cost-effective alternative to in-patient hysteroscopy under general anaesthesia. Like other outpatient gynaecological procedures, however, it has the potential to cause pain severe enough for the procedure to be abandoned.

Opioid analgesics are widely used for the control of moderate to severe pain. Tramadol hydrochloride, a synthetic opioid is an orally active, clinically effective centrally acting analgesic having a lower incidence of respiratory depression, cardiac depression, side effects on smooth muscle and abuse potential as compared to typical opioid agents.

Diclofenac is a non steroidal anti inflammatory drug which inhibits the cyclooxygenase enzyme.

The study will be conducted in the outpatient hysteroscopy clinic in Cairo university hospitals. All patients attending the outpatient hysteroscopy clinic will be invited to participate in the study. The invitation will include a clear full explanation of the study and patients will provide oral consent. Written informed consent is not needed since the procedure and Patients will be included in the study if they give written consents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Indication for operative outpatient hysteroscopy like endometrial biopsy, endometrial polyp, uterine septum, intrauterine adhesions, and loop retrieval.

排除标准

  • Known allergy to tramadol or diclofenac.
  • Diabetes, hypertension, gastritis, peptic ulcer, cardiac, renal or liver disease.

研究组 & 干预措施

Tramadol

Active Comparator

Women will receive oral tramadol 100 mg 1 hour before the procedure

干预措施: Tramadol (Drug)

Diclofenac

Active Comparator

Women will receive oral diclofenac 100 mg 1 hour before the procedure

干预措施: Diclofenac (Drug)

Placebo

Placebo Comparator

Women will receive an oral placebo 1 hour before the procedure

干预措施: Placebo (Drug)

结局指标

主要结局

Pain during the procedure as measured by the visual analogue scale

时间窗: 5 minutes after starting the procedure

Women will be asked to score their pain using a visual analogue scale

Pain after the procedure as measured by the visual analogue scale

时间窗: 30 minutes after completing the procedure

Women will be asked to score their pain using a visual analogue scale

次要结局

未报告次要终点

研究者

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

AbdelGany Hassan

Lecturer of Gynecology and Obstetrics

Cairo University

研究点 (2)

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