Efficacy of Diclofenac on Pain During Endometrial Sampling

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01762306
First received: December 11, 2012
Last updated: January 4, 2013
Last verified: September 2012
  Purpose

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 Intervention
Abnormal Uterine Bleeding Unrelated to Menstrual Cycle
Drug: Diclofenac Potassium
Drug: Folic Acid

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 90
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)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01762306

Contacts
Contact: Korakot Sirimai, Dr. (66)81-6140655 ksirimai@hotmail.com

Locations
Thailand
Faculty of Medicine Siriraj Hospital Mahidol University Recruiting
Bangkok, Thailand, 10700
Contact: Korakot Sirimai, Dr.    (66)81-6140655    ksirimai@hotmail.com   
Principal Investigator: Korakot Sirimai, Dr.         
Sub-Investigator: Tripop Lertbunnaphong, Dr.         
Sponsors and Collaborators
Mahidol University
  More Information

Publications:
Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01762306     History of Changes
Other Study ID Numbers: SIOGMVA001
Study First Received: December 11, 2012
Last Updated: January 4, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Hemorrhage
Metrorrhagia
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
Diclofenac
Folic Acid
Vitamin B Complex
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Vitamins
Micronutrients
Growth Substances
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 10, 2014