Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
试验速览
- 阶段
- 3 期
- 入组人数
- 210
- 主要终点
- Patient's perception of pain during the procedure
研究概览
简要总结
Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.
详细描述
Two hundreds and twenty five postmenopausal women undergoing outpatient hysteroscopy and endometrial biopsy will be randomly divided into three equal groups. To ensure blinding the investigators will use the double dummy technique in which group 1 will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally in addition to a placebo similar to Celecoxib, group 2 will receive dexketoprofen 25mg (neo ketadex 25, Marcryl, Egypt) in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol and a placebo similar to Celecoxib. All drugs will be given 2 hours before the procedure. An independent person will generate the allocation sequence using computer generated random numbers.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post menopausal women.
- •vaginal bleeding.
- •Endometrial thickness >4mm.
排除标准
- •Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal, liver disease.
- •Gastritis or peptic ulcer.
- •Allergy to Tramadol or dexketoprofen.
研究组 & 干预措施
tramadol
Drug: Tramadol Women will receive oral Tramadol 100 mg 2 hours before the procedure
Drug: Placebo 2 Women will receive an oral placebo similar to dexketoprofen 2 hours before the procedure
.
干预措施: Tramadol (Drug)
dexketoprofen
Drug: dexketoprofen Women will receive oral dexketoprofen 25mg 2 hours before the procedure
Drug: Placebo 1 Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.
干预措施: dexketoprofen (Drug)
placebo
Drug: Placebo 1 Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.
Drug: Placebo 2 Women will receive an oral placebo similar to dexketoprofen 2 hours before the procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Patient's perception of pain during the procedure
时间窗: 2 minutes after starting the procedure
The nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain.VAS of 0 indicates no pain and VAS of 10 indicates the worst possible experienced pain
次要结局
- Pain after the procedure(30 minutes after completing the procedure)
研究者
Ahmed Samy aly ashour
lecturer in obstetrics and gynecology
Cairo University