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

NCT01060696 | Unknown

• 1 other identifier: 615/2551
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Infertility; Saline infusion sonohysterography; Pain; Hyoscine; Mefenamic acid; women

Outcome Measures

Primary Outcomes (1)

• Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography

  Before, during and after the procedure

Secondary Outcomes (1)

• Patients satisfaction during saline infusion sonohysterography

  After the procedure

Study Arms (1)

Hyoscine, Mefenamic acid, Placebo

EXPERIMENTAL

Blind randomization to three groups. Mefenamic acid group Hyoscine group Placebo group

Drug: Mefenamic acid or Hyoscine or placebo

Interventions

Mefenamic acid or Hyoscine or placebo DRUG

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

Also known as: Ponstan (Mefenamic acid), Buscopan (Hyoscine-N-butylbromide)

Hyoscine, Mefenamic acid, Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• infertility female
• no history of HSG or Hysteroscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Siriraj hospital Mahidol university

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Infertility; Pain

Interventions

Mefenamic Acid; Scopolamine; Butylscopolammonium Bromide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Quaternary Ammonium Compounds; Amines

Study Officials

• Singpetch Suksompong, Doctor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2010
• First Posted: February 2, 2010
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 2, 2010

Record last verified: 2010-01

Locations

TH (1)