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临床试验/NCT02068209
NCT02068209已完成2 期

Role of Tramadol 50mg in Reducing Pain Associated With Outpatient Hysteroscopy: A Randomized Double Blind Placebo Controlled Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
140
试验地点
1
主要终点
Pain perceived by the patient during the procedure

研究概览

简要总结

The purpose of this study is to evaluate the role of Tramadol 50mg in reducing pain during outpatient hysteroscopy.

详细描述

This study is a prospective double blinded randomised controlled trial. 140 women will be recruited from the office 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 written consents. Only patients consenting to participate will be included in the trial.

Tramadol and placebo will be enclosed in sealed envelopes which will be numbered using a computer generated random table. Neither the patient nor the physician will be aware of the drug used. Patients will be categorized into 2 groups: Group I who will receive Tramadol 50mg (Tramadol, October Pharma, Giza, Egypt) 1 hour before the procedure, group II who will received a placebo acting as the control group.

Full history will be taken followed by general and local examination. The procedure will be done in the lithotomy position. Hysteroscopy will be done using a 5mm outer diameter continuous flow hysteroscope with a French working channel and a 30 degrees direction of view provided by Techno GmbH and CO. The hysteroscope will be introduced using the vaginoscopy technique, in which no speculum will be used. The cervix will be detected and the external os will be identified using the hysteroscope. The hysteroscope will be introduced in the uterine cavity. Saline will be used as the distension medium and the pressure will be set at 100mm Hg. The anterior wall, posterior wall and tubal ostea will be visualized, any polyps, adhesions septa, congenital malformations or submucous fibroids will be noted.

Base line characteristics will be compared and the main outcome measure will be patients' pain perception during the procedure and 30 minutes later, this will be determined using a visual analogue scale.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients referred for outpatient hysteroscopy
  • Consent to the procedure

排除标准

  • Premenstrual patients
  • Known cardiac disease
  • Known allergy to Tramadol

研究组 & 干预措施

Tramadol

Active Comparator

Patients will receive Tramadol 50mg 1 hour before outpatient hysteroscopy

干预措施: Tramadol (Drug)

Placebo

Placebo Comparator

Patients will receive a placebo 1 hour before the procedure.

干预措施: Placebo (Drug)

结局指标

主要结局

Pain perceived by the patient during the procedure

时间窗: 10 minutes after starting the procedure.

Pain will be assessed by a visual analogue scale 10 minutes after starting the procedure.

次要结局

  • Pain perceived by the patient 30 minutes after the procedure.(30 minutes after the procedure.)

研究者

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

AbdelGany Hassan

Dr Hassan

Cairo University

研究点 (1)

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