Efficacy of Diclofenac on Pain During Endometrial Sampling

NCT01762306 | Unknown

• 1 other identifier: SIOGMVA001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Diclofenac Potassium

EXPERIMENTAL

Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage

Drug: Diclofenac Potassium

Folic Acid

PLACEBO COMPARATOR

Folic acid 5 mg PO 1 hour prior to fractional curettage

Drug: Folic Acid

Interventions

Diclofenac Potassium DRUG

Also known as: Cataflam

Diclofenac Potassium

Folic Acid DRUG

Folic Acid

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (8)

• 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.

  PMID: 16047182 BACKGROUND

• 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.

  PMID: 18396369 BACKGROUND

• 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.

  PMID: 16357114 BACKGROUND

• 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.

  PMID: 16241013 BACKGROUND

• 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.

  PMID: 21901726 BACKGROUND

• 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.

  PMID: 19370609 BACKGROUND

• 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.

  PMID: 22619908 BACKGROUND

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

  BACKGROUND

MeSH Terms

Interventions

Diclofenac; Folic Acid

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Korakot Sirimai, Dr.

CONTACT

(66)81-6140655; ksirimai@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: January 7, 2013
• Study Start: November 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: January 7, 2013

Record last verified: 2012-09

Locations

TH (1)