An interventional study of Sublingual Misoprostol and Lidocaine pump spray in Pain During Hysteroscopy, sponsored by Dr. Sami Ulus Children's Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2012-10-31.
Sponsored by Dr. Sami Ulus Children's Hospital · Not applicable, Interventional, and Treatment
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.
Dr. Sami Ulus Children's Hospital is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo
Drug: Sublingual Misoprostol · Drug: Placebo (for Lidocaine)
Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo
Drug: Lidocaine pump spray · Drug: Placebo (for Misoprostol)
Also known as: Cytotec
Also known as: Xylocaine %10 pump spray
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
Patient VAS score immediately after the procedure
Time frame: Immediately after the procedure
Patient VAS score 10 minutes after the procedure
Time frame: 10 minutes after the procedure
Need for cervical dilation
Time frame: During the procedure
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Dr. Sami Ulus Children's Hospital