Efficacy of Diclofenac on Pain During Endometrial Sampling
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|ClinicalTrials.gov Identifier: NCT01762306|
Recruitment Status : Unknown
Verified September 2012 by Mahidol University.
Recruitment status was: Recruiting
First Posted : January 7, 2013
Last Update Posted : January 7, 2013
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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.
|Condition or disease||Intervention/treatment||Phase|
|Abnormal Uterine Bleeding Unrelated to Menstrual Cycle||Drug: Diclofenac Potassium Drug: Folic Acid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
Experimental: Diclofenac Potassium
Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage
Drug: Diclofenac Potassium
Other Name: Cataflam
Placebo Comparator: Folic Acid
Folic acid 5 mg PO 1 hour prior to fractional curettage
Drug: Folic Acid
- Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding [ Time Frame: 1 Year ]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.
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|Ages Eligible for Study:||35 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Thai women at the age over 35 years old
- Presenting with abnormal uterine bleeding and have a plan of performing fractional curettage
- uterine anomalies
- Pelvic inflammatory disease
- Uncontrolled medical conditions
- Known cases of gynecological diseases such as gynecological malignancy, abnormal pap smear
- NSAIDs allergy
- contraindicate to NSAIDs use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762306
|Contact: Korakot Sirimai, Dr.||(66)firstname.lastname@example.org|
|Faculty of Medicine Siriraj Hospital Mahidol University||Recruiting|
|Bangkok, Thailand, 10700|
|Contact: Korakot Sirimai, Dr. (66)81-6140655 email@example.com|
|Principal Investigator: Korakot Sirimai, Dr.|
|Sub-Investigator: Tripop Lertbunnaphong, Dr.|
|Responsible Party:||Mahidol University|
|Other Study ID Numbers:||
|First Posted:||January 7, 2013 Key Record Dates|
|Last Update Posted:||January 7, 2013|
|Last Verified:||September 2012|
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Peripheral Nervous System Agents
Molecular Mechanisms of Pharmacological Action