Efficacy of Diclofenac on Pain During Endometrial Sampling
Recruitment status was Recruiting
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.
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
Drug: Diclofenac Potassium
Drug: Folic Acid
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding|
- 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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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|
Please refer to this study by its ClinicalTrials.gov identifier: 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.|