Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Pain Relief in Office Hysteroscopy: A Randomized, Double Blind, Placebo-Controlled Trial
| Registry | NCT01718314 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 138 (Actual) |
| Sponsor | Dr. Sami Ulus Children's Hospital (Other) |
| Conditions | Pain During Hysteroscopy |
| Interventions | Sublingual Misoprostol, Lidocaine pump spray, Placebo (for Misoprostol), Placebo (for Lidocaine) (Drug) |
| Dates | start 2008-03-01, primary completion 2009-12-01, completion 2010-03-01, first posted 2012-10-31, last updated 2012-10-31 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain During Hysteroscopy All trials of Sublingual Misoprostol All trials of Lidocaine pump spray
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
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Sublingual Misoprostol & Lidocaine placebo | Experimental | Drug: Sublingual Misoprostol; Drug: Placebo (for Lidocaine) | Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo |
| Lidocaine Pump Spray & Misoprostol placebo | Experimental | Drug: Lidocaine pump spray; Drug: Placebo (for Misoprostol) | Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo |
Sex: Female, ages: 18 Years to 51 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Dr Sami Ulus Maternity and Children Training and Research Hospital | Ankara | Turkey (Türkiye) |