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
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.
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)email@example.com|
|Faculty of Medicine Siriraj Hospital Mahidol University||Recruiting|
|Bangkok, Thailand, 10700|
|Contact: Korakot Sirimai, Dr. (66)81-6140655 firstname.lastname@example.org|
|Principal Investigator: Korakot Sirimai, Dr.|
|Sub-Investigator: Tripop Lertbunnaphong, Dr.|