Efficacy of Diclofenac on Pain During Endometrial Sampling

Study Overview
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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.

Official Title
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Efficacy for Acute Pain Alleviation of 50 mg Diclofenac 1 Hour Prior to Endometrial Sampling in Cases of Abnormal Uterine Bleeding

Conditions
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Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Intervention / Treatment
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* Drug: Diclofenac Potassium
* Drug: Folic Acid


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Potassium<br>Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage | Drug: Diclofenac Potassium<br> <br> * Other names: Cataflam;|
| Placebo Comparator: Folic Acid<br>Folic acid 5 mg PO 1 hour prior to fractional curettage | Drug: Folic Acid<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of Diclofenac Potassium for additional acute pain control in patient undergoing fractional curettage under paracervical block due to abnormal uterine bleeding | 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. | 1 Year |