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

Sponsor

Mahidol University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01060696

Collaborator

Siriraj Hospital (Other)

138

Enrollment

Location

Arm

15.9

Duration (Months)

8.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Mefenamic acid or Hyoscine or placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

138 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

May 1, 2010

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography [Before, during and after the procedure]

Secondary Outcome Measures

Patients satisfaction during saline infusion sonohysterography [After the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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