Text Size

Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sertac ESIN, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier:
NCT01718314
First received: October 29, 2012
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

Hysteroscopy is an instrument to visualize the interior walls of uterus (womb) and it enables the doctor to do minor operative procedures. Although it causes little discomfort, sometimes it may be disturbing for the patient. This pain is usually perceived during the passage of the instrument through the cervix (neck of the womb). The investigators would like to minimize this pain by two drugs: Misoprotol and lidocaine


Condition Intervention
Pain During Hysteroscopy
 Drug: Sublingual Misoprostol
Drug: Lidocaine pump spray
Drug: Placebo (for Misoprostol)
Drug: Placebo (for Lidocaine)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dr. Sami Ulus Children's Hospital:

Primary Outcome Measures:
  • Patient VAS score immediately after the procedure [ Time Frame: Immediately after the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient VAS score 10 minutes after the procedure [ Time Frame: 10 minutes after the procedure ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Need for cervical dilation [ Time Frame: During the procedure ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sublingual Misoprostol & Lidocaine placebo
Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
 Drug: Sublingual Misoprostol
Other Name: Cytotec
Drug: Placebo (for Lidocaine)
The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray
Experimental: Lidocaine Pump Spray & Misoprostol placebo
Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo
 Drug: Lidocaine pump spray
Other Name: Xylocaine %10 pump spray
Drug: Placebo (for Misoprostol)
Lactose filler, the pharmacy-produced pills identical to original misoprostol pill

Detailed Description:

Outpatient or office hysteroscopy has become the 'gold standard' for the investigation of the intrauterine abnormalities. This minimal invasive modality provides brilliant and clear visualization of the entire uterine cavity and besides this, by the operative channel, minor procedures may easily be performed in the office setting which is priceless for the gynecologist. However, pain related to the procedure may make the procedure uncomfortable for the patient and the physician. Together with the operative time, hysteroscope diameter is considered as the main factor influencing pain. The pain perceived during hysteroscopy may be reduced by using a smaller diameter hysteroscope or by using anesthesia, which decreases pain perception.

In this prospective, randomized, double blind, placebo controlled study, we aim to compare the effectiveness of sublingual misoprostol versus lidocaine pump spray for pain relief during office hysteroscopy.

  Eligibility

Ages Eligible for Study:   18 Years to 51 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women in the proliferative phase of the menstrual cycle with no contraindication for hysteroscopy

Exclusion Criteria:

  • vaginal bleeding at the time of the procedure
  • known sensitivity to lidocaine (amide group local anesthetics) or prostaglandins
  • epilepsy
  • significantly impaired respiratory or cardiac conduction functions
  • hypertension
  • glaucoma
  • renal failure
  • acute liver disease
  • uncontrolled diabetes mellitus
  • pregnancy or suspicion of pregnancy
  • pelvic inflammatory disease
  • cervical operation history
  • vaginismus.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718314

Locations
Turkey
Dr Sami Ulus Maternity and Children Training and Research Hospital
Ankara, Turkey, 06090
Sponsors and Collaborators
Dr. Sami Ulus Children's Hospital
Investigators
Study Chair: Tuncay Kucukozkan, Professor Sami Ulus Maternity and Childrens Hospital
  More Information

Publications:

Responsible Party: Sertac ESIN, Obstetrician and Gynecologist, Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov Identifier: NCT01718314     History of Changes
Other Study ID Numbers: HEK 11/33-21
Study First Received: October 29, 2012
Last Updated: October 30, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Dr. Sami Ulus Children's Hospital:
Hysteroscopy
Misoprostol
Lidocaine
Visual analogue score

Additional relevant MeSH terms:
Lidocaine
Misoprostol
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
 Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on May 19, 2013