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Tramadol Versus Celecoxib in Reducing Pain Associated With IUD Insertion

NCT02827487 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2019-04-08

No results posted yet for this study

Summary

Two hundred and ten women requesting IUD insertion 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 (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 in addition to a placebo similar to Celecoxib. All the drugs will be given 2 hour before the procedure.

After insertion of the IUD the women's pain perception will be assessed using a visual analogue scale (VAS) graduated from zero to 10 with zero corresponding to no pain and 10 corresponding to the worst possible pain.

Conditions

Interventions

DRUG

Tramadol

Women will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally 2 hours before IUD insertion.

DRUG

Celecoxib

Women will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) orally 2 hours before IUD insertion.

DRUG

Placebo 1

Women will receive a placebo similar to Tramadol orally 2 hours before IUD insertion.

DRUG

Placebo 2

Women will receive a placebo similar to Celecoxib orally 2 hours before IUD insertion.

PROCEDURE

IUD

IUD insertion

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
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-01
Primary Completion
2020-07-01
Completion
2020-07-01

Countries

  • Egypt

Study Locations

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Entities

Diseases

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 NCT02827487 on ClinicalTrials.gov