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Efficacy of Diclofenac on Pain During Endometrial Sampling

Primary Purpose

Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Diclofenac Potassium
Folic Acid
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Diclofenac Potassium

Folic Acid

Arm Description

Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage

Folic acid 5 mg PO 1 hour prior to fractional curettage

Outcomes

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
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.

Secondary Outcome Measures

Full Information

First Posted
December 11, 2012
Last Updated
January 4, 2013
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT01762306
Brief Title
Efficacy of Diclofenac on Pain During Endometrial Sampling
Official Title
Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac Potassium
Arm Type
Experimental
Arm Description
Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage
Arm Title
Folic Acid
Arm Type
Placebo Comparator
Arm Description
Folic acid 5 mg PO 1 hour prior to fractional curettage
Intervention Type
Drug
Intervention Name(s)
Diclofenac Potassium
Other Intervention Name(s)
Cataflam
Intervention Type
Drug
Intervention Name(s)
Folic Acid
Primary Outcome Measure Information:
Title
Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding
Description
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.
Time Frame
1 Year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Korakot Sirimai, Dr.
Phone
(66)81-6140655
Email
ksirimai@hotmail.com
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Korakot Sirimai, Dr.
Phone
(66)81-6140655
Email
ksirimai@hotmail.com
First Name & Middle Initial & Last Name & Degree
Korakot Sirimai, Dr.
First Name & Middle Initial & Last Name & Degree
Tripop Lertbunnaphong, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16047182
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. doi: 10.1007/s00404-005-0041-y. Epub 2005 Jul 27.
Results Reference
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PubMed Identifier
18396369
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.
Results Reference
background
PubMed Identifier
16357114
Citation
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.
Results Reference
background
PubMed Identifier
16241013
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.
Results Reference
background
PubMed Identifier
21901726
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.
Results Reference
background
PubMed Identifier
19370609
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.
Results Reference
background
PubMed Identifier
22619908
Citation
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.
Results Reference
background
Citation
Hinchy S, Ordman, Burrell A, Vella L, Ward L. Guidelines for the Management of Acute Pain in Adults. NHS trust; 2008.
Results Reference
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Efficacy of Diclofenac on Pain During Endometrial Sampling

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