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Tramadol Versus Celecoxib for Reducing Pain During Operative Office Hysteroscopy

NCT02736071 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2016-07-06

No results posted yet for this study

Summary

Two hundred and ten women undergoing operative hysteroscopy will be randomly divided into three equal groups. To ensure blinding the double dummy technique will be used in which group 1 will receive Tramadol 100mg orally in addition to a placebo similar to Celecoxib, group 2 will receive Celecoxib 200mg in addition to a placebo similar to Tramadol, and group 3 will received a placebo similar to Tramadol in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour 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 100mg 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, MRCOG, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 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 NCT02736071 on ClinicalTrials.gov