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Oral Tramadol Versus Oral Dexketoprofen for Reducing Pain During Office Hysteroscopy

NCT03585036 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2018-07-12

No results posted yet for this study

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.

Conditions

  • Hysteroscopy

Interventions

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.

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

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AHMED SAMY, MD · lecturer in obstetrics and gynecology,cairo university

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-31
Primary Completion
2018-09-30
Completion
2018-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585036 on ClinicalTrials.gov