Comparison of Sublingual Misoprostol Versus Lidocaine Spray for Hysteroscopy

Dr. Sami Ulus Children's Hospital

Status: Completed

Conditions: Pain During Hysteroscopy

Treatments: Drug: Sublingual Misoprostol; Drug: Lidocaine pump spray; Drug: Placebo (for Misoprostol); Drug: Placebo (for Lidocaine)

Study type: Interventional

Funder types: Other

Identifiers

NCT01718314

HEK 11/33-21

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 patients

Sex: Female

Ages: 18 to 51 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

138 participants in 2 patient groups

Sublingual Misoprostol & Lidocaine placebo

Experimental group

Description:

Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo

Treatment:

Drug: Placebo (for Lidocaine)

Drug: Sublingual Misoprostol

Lidocaine Pump Spray & Misoprostol placebo

Experimental group

Description:

Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo

Treatment:

Drug: Placebo (for Misoprostol)

Drug: Lidocaine pump spray