Efficacy of Diclofenac on Pain During Endometrial Sampling - Full Text View

Purpose

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	Intervention
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle	Drug: Diclofenac Potassium Drug: Folic Acid

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: B Vitamins Potassium Vaginal Bleeding

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

U.S. FDA Resources

Further study details as provided by Mahidol University:

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 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	90
Study Start Date:	November 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	35 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762306

Contacts

Contact: Korakot Sirimai, Dr.

(66)81-6140655

ksirimai@hotmail.com

Locations

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. 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. PubMed PMID: 18396369.

Macintyre PE, Walker S, Power I, Schug SA. Acute pain management: scientific evidence revisited. Br J Anaesth. 2006 Jan;96(1):1-4.

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. Review.

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. Review.

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.

Responsible Party:	Mahidol University
ClinicalTrials.gov Identifier:	NCT01762306 History of Changes
Other Study ID Numbers:	SIOGMVA001
Study First Received:	December 11, 2012
Last Updated:	January 4, 2013
Health Authority:	Thailand: Ethical Committee

Additional relevant MeSH terms:

Uterine Hemorrhage
Hemorrhage
Metrorrhagia
Adenoma
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Diclofenac
Folic Acid
Vitamin B Complex
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013