Efficacy of Diclofenac on Pain During Endometrial Sampling

NCT ID: NCT01762306

Last Updated: 2013-01-07

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Diclofenac Potassium

Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage

Group Type EXPERIMENTAL

Diclofenac Potassium

Intervention Type DRUG

Folic Acid

Folic acid 5 mg PO 1 hour prior to fractional curettage

Group Type PLACEBO_COMPARATOR

Folic Acid

Intervention Type DRUG

Interventions

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Diclofenac Potassium

Intervention Type DRUG

Folic Acid

Intervention Type DRUG

Other Intervention Names

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Cataflam

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Korakot Sirimai, Dr.

Role: CONTACT

(66)81-6140655

Facility Contacts

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Korakot Sirimai, Dr.

Role: primary

(66)81-6140655

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.

Reference Type BACKGROUND
PMID: 16047182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18396369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16357114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16241013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21901726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19370609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22619908 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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SIOGMVA001

Identifier Type: -

Identifier Source: org_study_id

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