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

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ClinicalTrials.gov Identifier: NCT01060696
Recruitment Status : Unknown
Verified January 2010 by Mahidol University.
Recruitment status was:  Active, not recruiting
First Posted : February 2, 2010
Last Update Posted : February 2, 2010
Sponsor:
Collaborator:
Siriraj Hospital
Information provided by:
Mahidol University

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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)




Primary Outcome Measures :
  1. 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 :
  1. Patients satisfaction during saline infusion sonohysterography [ Time Frame: After the procedure ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060696


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

Responsible Party: Singpetch Suksompong, Mahidol University
ClinicalTrials.gov Identifier: NCT01060696     History of Changes
Other Study ID Numbers: 615/2551
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010

Keywords provided by Mahidol University:
Infertility
Saline infusion sonohysterography
Pain
Hyoscine
Mefenamic acid
women

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