Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

NCT ID: NCT03585036

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2018-10-31

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.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

dexketoprofen

Intervention Type: DRUG

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.

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

.

Group Type: ACTIVE_COMPARATOR

Tramadol

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

lecturer in obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED SAMY, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer in obstetrics and gynecology,cairo university

Central Contacts

AHMED SAMY, MD

Role: CONTACT

ahmedsamy8233@gmail.com

01100681167

Other Identifiers

tramadol

Identifier Type: -

Identifier Source: org_study_id