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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Mahidol University.
Recruitment status was:  Active, not recruiting
Siriraj Hospital
Information provided by:
Mahidol University Identifier:
First received: January 31, 2010
Last updated: February 1, 2010
Last verified: January 2010
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 Intervention
Infertility Drug: Mefenamic acid or Hyoscine or placebo

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Pain relief by oral Mefenamic acid or Hyoscine and placebo during saline infusion sonohysterography [ Time Frame: Before, during and after the procedure ]

Secondary Outcome Measures:
  • Patients satisfaction during saline infusion sonohysterography [ Time Frame: After the procedure ]

Estimated Enrollment: 138
Study Start Date: January 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)


Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01060696

Siriraj hospital Mahidol university
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Siriraj Hospital
Principal Investigator: Singpetch Suksompong, Doctor
  More Information

Responsible Party: Singpetch Suksompong, Mahidol University Identifier: NCT01060696     History of Changes
Other Study ID Numbers: 615/2551
Study First Received: January 31, 2010
Last Updated: February 1, 2010

Keywords provided by Mahidol University:
Saline infusion sonohysterography
Mefenamic acid

Additional relevant MeSH terms:
Genital Diseases, Female
Genital Diseases, Male
Scopolamine Hydrobromide
Butylscopolammonium Bromide
Mefenamic Acid
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017