Efficacy of Diclofenac on Pain During Endometrial Sampling

Not Applicable

• Conditions: Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
• Interventions: Drug: Diclofenac Potassium; Drug: Folic Acid

• Registration Number: NCT01762306
• Lead Sponsor: Mahidol University

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-11
• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2013-01-04
• Last Update Submitted: 2013-01-04
• Study First Posted: 2013-01-07
• Last Update Posted: 2013-01-07
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac Potassium	Diclofenac Potassium	Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage
Folic Acid	Folic Acid	Folic acid 5 mg PO 1 hour prior to fractional curettage

Primary Outcome Measures

Name	Time	Method
Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding	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.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital Mahidol University; 🇹🇭 Bangkok, Thailand