Title
Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy
Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
Phase
N/ALead Sponsor
Dr. Sami Ulus Children's HospitalStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Pain During HysteroscopyIntervention/Treatment
lidocaine misoprostol ...Study Participants
138Hysteroscopy 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
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.
Lactose filler, the pharmacy-produced pills identical to original misoprostol pill
The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray
Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo
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.
