Efficacy of Diclofenac on Pain During Endometrial Sampling

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01762306
• Other study ID #: SIOGMVA001
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2012
• Last updated: January 4, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2012
• Source: Mahidol University
• Contact: Korakot Sirimai, Dr.
• Phone: (66)81-6140655
• Email: ksirimai[@]hotmail.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
• Metrorrhagia
• Uterine Hemorrhage

Intervention

Drug:
• Diclofenac Potassium

• Folic Acid

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. Update in: Cochrane Database Syst Rev. 2015;7:CD004768. — View Citation

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

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

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. — View Citation

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. Update in: Cochrane Database Syst Rev. 2015;9:CD008659. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding	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	No