NCT01718314

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Dr. Sami Ulus Children's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 51 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Pain During Hysteroscopy

Interventions

Type	Name	Description
DRUG	Sublingual Misoprostol
DRUG	Lidocaine pump spray
DRUG	Placebo (for Misoprostol)	Lactose filler, the pharmacy-produced pills identical to original misoprostol pill
DRUG	Placebo (for Lidocaine)	The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray

Timeline

• Start date: 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 across 1 country: Turkey (Türkiye)