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临床试验/NCT01718314
NCT01718314已完成不适用

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial

Dr. Sami Ulus Children's Hospital1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2008年3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
138
试验地点
1
主要终点
Patient VAS score immediately after the procedure

研究概览

简要总结

Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine

详细描述

Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception.

In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.

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 51 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy

排除标准

  • vaginal bleeding at the time of the procedure
  • known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
  • significantly impaired respiratory or cardiac conduction functions
  • hypertension
  • renal failure
  • acute liver disease
  • uncontrolled diabetes mellitus
  • pregnancy or suspicion of pregnancy
  • pelvic inflammatory disease
  • cervical operation history
  • vaginismus.

研究组 & 干预措施

Sublingual Misoprostol & Lidocaine placebo

Experimental

Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo

干预措施: Sublingual Misoprostol (Drug)

Sublingual Misoprostol & Lidocaine placebo

Experimental

Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo

干预措施: Placebo (for Lidocaine) (Drug)

Lidocaine Pump Spray & Misoprostol placebo

Experimental

Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo

干预措施: Lidocaine pump spray (Drug)

Lidocaine Pump Spray & Misoprostol placebo

Experimental

Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo

干预措施: Placebo (for Misoprostol) (Drug)

结局指标

主要结局

Patient VAS score immediately after the procedure

时间窗: Immediately after the procedure

次要结局

  • Patient VAS score 10 minutes after the procedure(10 minutes after the procedure)

研究者

发起方
Dr. Sami Ulus Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sertac ESIN

Obstetrician and Gynecologist

Dr. Sami Ulus Children's Hospital

研究点 (1)

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