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临床试验/NCT02736071
NCT02736071Unknown3 期

Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy: A Double Blind Placebo Controlled Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2016年6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
1
主要终点
Pain perception during the procedure

研究概览

简要总结

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).

详细描述

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.

All procedures will be scheduled to be done postmenstrual or after cessation of bleeding in case of metrorrhagia and will be done in the lithotomy position. The procedures will be performed using 30 degree angle 2.7 mm rigid hysteroscope with a 5mm outer diameter continuous flow hysteroscope with a 5 French working channel, a Teknolight 180 XA light source, and a Xenon high density fibre optic light cable 3.5mm, 2300mm Light cable without adaptors and a T Camera teknocam 2000S pro. All the equipment are provided by Tekno GmbH and Co®, Germany.

Vaginoscopic approach will be used for insertion of the hysteroscope in all cases. The hysteroscope will be gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS). VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain. Patients will also be asked to report any side effects. The main outcome measure will be patients' pain perception during the procedure.

Statistics:

Quantitative data will be statistically represented in terms of mean ± standard deviation (± SD) while categorical data will be represented as frequency and percentage. Comparison of quantitative data will be done using ANOVA test for independent samples while categorical data will be compared using Chi squared test or Fisher exact test when appropriate. A probability value (p value) less than 0.05 will be considered significant.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Indication for operative outpatient hysteroscopy, indications will include endometrial biopsy, polypectomy, septum resection, intra-uterine device removal and adhesiolysis.

排除标准

  • Submucous myomas.
  • Known medical disorders like uncontrolled diabetes, hypertension, cardiac, renal or liver disease.
  • Gastritis or peptic ulcer.
  • Allergy to Tramadol or Celecoxib.

研究组 & 干预措施

Celecoxib

Active Comparator

Women will receive oral Celecoxib 200mg 2 hours before the procedure

干预措施: Celecoxib (Drug)

Tramadol

Active Comparator

Women will receive oral Tramadol 100 mg 2 hours before the procedure

干预措施: Tramadol (Drug)

Placebo

Placebo Comparator

Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure

干预措施: Placebo 1 (Drug)

Placebo

Placebo Comparator

Women will receive an oral placebo similar to Tramadol and an oral placebo similar to Celecoxib 2 hours before the procedure

干预措施: Placebo 2 (Drug)

结局指标

主要结局

Pain perception during the procedure

时间窗: 5 minutes after starting the procedure

A nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain

次要结局

  • Pain perception after the procedure(30 minutes after completing the procedure)

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 (1)

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