Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

Conditions
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Hysteroscopy

Intervention / Treatment
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* Drug: dexketoprofen
* Drug: Tramadol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexketoprofen<br>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. | Drug: dexketoprofen<br>* 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.<br>|
| Active Comparator: tramadol<br>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 . | Drug: Tramadol<br>* 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<br>|
| Placebo Comparator: placebo<br>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 | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's perception of pain during 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 | 2 minutes after starting the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain after the procedure | The nurse will hand the patient a VAS and the patient will mark the point corresponding to her pain. | 30 minutes after completing the procedure |