Clinical trial NCT03585036: Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy
Official title: Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy in Post Menopausal Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-07-12
Enrollment: 210
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Post menopausal women.
* vaginal bleeding.
* Endometrial thickness \>4mm.

Exclusion Criteria:

* Medical disorders like uncontrolled diabetes or hypertension, cardiac, renal, liver disease.
* Gastritis or peptic ulcer.
* Allergy to Tramadol or dexketoprofen.

Primary outcomes:
measure: Patient's perception of pain during the procedure
timeFrame: 2 minutes after starting the procedure
Secondary outcomes:
measure: Pain after the procedure
timeFrame: 30 minutes after completing the procedure
Other outcomes:
Locations:
Study officials:
affiliation: lecturer in obstetrics and gynecology,cairo university
name: AHMED SAMY, MD
role: PRINCIPAL_INVESTIGATOR
References: