Hysteroscopy Clinical Trial
Official title:
Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
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.
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.
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