Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy
Information source: Dr. Sami Ulus Children's Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain During Hysteroscopy
Intervention: Sublingual Misoprostol (Drug); Lidocaine pump spray (Drug); Placebo (for Misoprostol) (Drug); Placebo (for Lidocaine) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Dr. Sami Ulus Children's Hospital Official(s) and/or principal investigator(s): Tuncay Kucukozkan, Professor, Study Chair, Affiliation: Sami Ulus Maternity and Childrens Hospital
Summary
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
Clinical Details
Official title: Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Patient VAS score immediately after the procedure
Secondary outcome: Patient VAS score 10 minutes after the procedure
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
Minimum age: 18 Years.
Maximum age: 51 Years.
Gender(s): Female.
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.
Locations and Contacts
Dr Sami Ulus Maternity and Children Training and Research Hospital, Ankara 06090, Turkey
Additional Information
Starting date: March 2008
Last updated: October 30, 2012
|