Efficacy of Diclofenac on Pain During Endometrial Sampling
NCT ID: NCT01762306
Last Updated: 2013-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2012-11-30
2013-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Diclofenac Potassium
Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage
Diclofenac Potassium
Folic Acid
Folic acid 5 mg PO 1 hour prior to fractional curettage
Folic Acid
Interventions
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Diclofenac Potassium
Folic Acid
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presenting with abnormal uterine bleeding and have a plan of performing fractional curettage
Exclusion Criteria
* 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
35 Years
FEMALE
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Locations
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Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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SIOGMVA001
Identifier Type: -
Identifier Source: org_study_id
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