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Tramadol Versus Celecoxib for Reducing Pain During Office Hysteroscopy in Post Menopausal Women

NCT02736019 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2016-07-06

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 Celecoxib 200mg (Celebrex® 200, Pfizer, USA) 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.

Patient's perception of pain will be assessed for each group during the procedure, immediately after and 30 min after the procedure with the use of visual analogue scale (VAS).

Conditions

  • Hysteroscopy

Interventions

DRUG

Celecoxib

Women will receive oral Celecoxib 200mg 2 hours before the procedure

DRUG

Tramadol

Women will receive oral Tramadol 100 mg 2 hours before the procedure

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 celecoxib 2 hours before the procedure

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AbdelGany M Hassan · 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
2016-06-30
Primary Completion
2017-04-30

Countries

  • Egypt

Study Locations

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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 NCT02736019 on ClinicalTrials.gov