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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Mahidol University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Siriraj Hospital
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01060696
First received: January 31, 2010
Last updated: February 1, 2010
Last verified: January 2010
  Purpose

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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients satisfaction during saline infusion sonohysterography [ Time Frame: After the procedure ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060696

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

No publications provided

Responsible Party: Singpetch Suksompong, Mahidol University
ClinicalTrials.gov Identifier: NCT01060696     History of Changes
Other Study ID Numbers: 615/2551
Study First Received: January 31, 2010
Last Updated: February 1, 2010
Health Authority: Thailand: Ethical Committee

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
Butylscopolammonium Bromide
Scopolamine
Mefenamic Acid
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014