Efficacy of Diclofenac on Pain During Endometrial Sampling

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ClinicalTrials.gov Identifier: NCT01762306

Recruitment Status : Unknown

Verified September 2012 by Mahidol University.
Recruitment status was: Recruiting

First Posted : January 7, 2013

Last Update Posted : January 7, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Mahidol University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle	Drug: Diclofenac Potassium Drug: Folic Acid	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	90 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding
Study Start Date :	November 2012
Estimated Primary Completion Date :	June 2013
Estimated Study Completion Date :	June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Folic Acid Potassium

Drug Information available for: Folic acid Vitamin B Complex Diclofenac sodium Diclofenac potassium Diclofenac

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Diclofenac Potassium Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage	Drug: Diclofenac Potassium Other Name: Cataflam
Placebo Comparator: Folic Acid Folic acid 5 mg PO 1 hour prior to fractional curettage	Drug: Folic Acid

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	35 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762306

Contacts

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Contact: Korakot Sirimai, Dr.	(66)81-6140655	ksirimai@hotmail.com

Locations

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Thailand
Faculty of Medicine Siriraj Hospital Mahidol University	Recruiting
Bangkok, Thailand, 10700
Contact: Korakot Sirimai, Dr. (66)81-6140655 ksirimai@hotmail.com
Principal Investigator: Korakot Sirimai, Dr.
Sub-Investigator: Tripop Lertbunnaphong, Dr.

Sponsors and Collaborators

Mahidol University

More Information

Publications:

Poomtavorn Y, Phupong V. Prospective randomized, double-blinded, placebo-controlled trial of preoperative rofecoxib for pain relief in uterine curettage. Arch Gynecol Obstet. 2005 Dec;273(2):115-8. doi: 10.1007/s00404-005-0041-y. Epub 2005 Jul 27.

Manyou B, Phupong V. Prospective randomized, double-blinded, placebo-controlled trial of preoperative etoricoxib for pain relief in uterine fractional curettage under paracervical block. Eur J Obstet Gynecol Reprod Biol. 2008 Sep;140(1):90-4. doi: 10.1016/j.ejogrb.2008.02.017. Epub 2008 Apr 8.

Macintyre PE, Walker S, Power I, Schug SA. Acute pain management: scientific evidence revisited. Br J Anaesth. 2006 Jan;96(1):1-4. doi: 10.1093/bja/aei295. No abstract available.

Buppasiri P, Tangmanowutikul S, Yoosuk W. Randomized controlled trial of mefenamic acid vs paracervical block for relief of pain for outpatient uterine curettage. J Med Assoc Thai. 2005 Jul;88(7):881-5.

Moore RA, Derry S, McQuay HJ, Wiffen PJ. Single dose oral analgesics for acute postoperative pain in adults. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD008659. doi: 10.1002/14651858.CD008659.pub2.

Derry P, Derry S, Moore RA, McQuay HJ. Single dose oral diclofenac for acute postoperative pain in adults. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD004768. doi: 10.1002/14651858.CD004768.pub2.

Boonyarangkul A, Leksakulchai O. Comparison of level of pain between using manual vacuum aspiration and sharp curettage in management of abnormal uterine bleeding. J Med Assoc Thai. 2011 Dec;94 Suppl 7:S57-61.

Hinchy S, Ordman, Burrell A, Vella L, Ward L. Guidelines for the Management of Acute Pain in Adults. NHS trust; 2008.

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Responsible Party:	Mahidol University
ClinicalTrials.gov Identifier:	NCT01762306
Other Study ID Numbers:	SIOGMVA001
First Posted:	January 7, 2013 Key Record Dates
Last Update Posted:	January 7, 2013
Last Verified:	September 2012

Additional relevant MeSH terms:

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Uterine Hemorrhage Metrorrhagia Hemorrhage Pathologic Processes Uterine Diseases Folic Acid Diclofenac Hematinics Vitamin B Complex Vitamins Micronutrients	Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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