Efficacy of Diclofenac on Pain During Endometrial Sampling

Mahidol University

Status: Unknown

Conditions: Abnormal Uterine Bleeding Unrelated to Menstrual Cycle

Treatments: Drug: Folic Acid; Drug: Diclofenac Potassium

Study type: Interventional

Funder types: Other

Identifiers

NCT01762306

SIOGMVA001

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 2 patient groups, including a placebo group

Diclofenac Potassium

Experimental group

Description:

Diclofenac Potassium 50 mg PO 1 hour prior to fractional curettage

Treatment:

Drug: Diclofenac Potassium

Folic Acid

Placebo Comparator group

Description:

Folic acid 5 mg PO 1 hour prior to fractional curettage

Treatment:

Drug: Folic Acid