Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women

February 1, 2010 updated by: Mahidol University

Efficacy of Mefenamic Acid and Hyoscine for Pain Relief During Saline Infusion Sonohysterography in Infertile Women. A Double Blind Randomized Controlled Trial

The infertility patients who are performed saline infusion sonohysterography (SIS) for studying the pathology inside the uterine cavity has pain. From pilot study the pain score is 6.80. It will have more benefits if we can manage this procedure with less or no pain. Many studies have tried to decrease pain such as types of catheter, intrauterine lidocaine infusion. Some have real effects but no study with oral Mefenamic acid or Hyoscine before the procedure.The drugs are safe and easy to administration and chief.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertility female
  • no history of HSG or Hysteroscopy

Exclusion Criteria:

  • vaginal or pelvic infection
  • abnormal Pap smear
  • contraindications for Mefenamic acid including upper and lower GI ulcers, bleeding disorder, Asthma or allergies, renal disease, using Warfarin,Aspirin, Lithium, history of Mefenamic acid or Hyoscine allergies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyoscine, Mefenamic acid, Placebo
Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group
Drug: Mefenamic acid or Hyoscine or placebo
Mefenamic acid 500 mg. single oral use 30 minutes before SIS Hyoscine 10 mg. single oral use 30 minutes before SIS Placebo single oral use 30 minutes before SIS
Other Names:
  • Ponstan (Mefenamic acid)
  • Buscopan (Hyoscine-N-butylbromide)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography
Time Frame: Before, during and after the procedure
Before, during and after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Patients satisfaction during saline infusion sonohysterography
Time Frame: After the procedure
After the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

Investigators

  • Principal Investigator: Singpetch Suksompong, Doctor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

January 31, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 615/2551

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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