Efficacy of Diclofenac on Pain During Endometrial Sampling

January 4, 2013 updated by: Mahidol University

Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding

Abnormal uterine bleeding is common in Thai women. Traditionally, because of a larger number of patients, the diagnosis of its cause is performed via fractional curettage under local anesthesia such as paracervical nerve block or intravenous meperidine.

Pain is one of a common adverse effect of this procedure and this topic should be concerned by a responsible doctor.

NSAIDs, Diclofenac Potassium in this study, is known as a drug which is effective for pain control and is as effective as coxib in acute pain management. Because of its cost, easy accessible and easy administration, Diclofenac Potassium was selected to be used in this study. Its onset of action is about 1 hour and only one dose of this drug do not cause any serious side effects.

The hypothesis of this study is that "Diclofenac Potassium has an additional effectiveness for acute pain control in patients undergoing fractional curettage under paracervical nerve block due to abnormal uterine bleeding" Double blind randomised controlled trial was performed in this study with 45 patients included in each group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of medicine Siriraj Hospital Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Thai women at the age over 35 years old
  • Presenting with abnormal uterine bleeding and have a plan of performing fractional curettage

Exclusion Criteria:

  • uterine anomalies
  • pregnancy
  • Pelvic inflammatory disease
  • Uncontrolled medical conditions
  • Known cases of gynecological diseases such as gynecological malignancy, abnormal pap smear
  • NSAIDs allergy
  • contraindicate to NSAIDs use

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diclofenac Potassium
Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage
Drug: Diclofenac Potassium
Other Names:
  • Cataflam
Placebo Comparator: Folic Acid
Folic acid 5 mg PO 1 hour prior to fractional curettage
Drug: Folic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding
Time Frame: 1 Year
Effectiveness of oral 50 mg Diclofenac Potassium was measured by pain score using visual dialogue scale during operation and 30, 60, 90 and 120 minutes after procedure.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

December 11, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (Estimate)

January 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 4, 2013

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIOGMVA001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Clinical Trials on Diclofenac Potassium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe