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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual Misoprostol & Lidocaine placebo | Experimental | Misoprostol 200 µg sublingually single dose and Lidocaine spray placebo |
|
| Lidocaine Pump Spray & Misoprostol placebo | Experimental | Lidocaine Pump spray, 6 sprays to cervix (60 mg totally) and sublingual misoprotol placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual Misoprostol | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient VAS score immediately after the procedure | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient VAS score 10 minutes after the procedure | 10 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Need for cervical dilation | During the procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuncay Kucukozkan, Professor | Sami Ulus Maternity and Childrens Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Sami Ulus Maternity and Children Training and Research Hospital | Ankara | 06090 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17516956 | Result | van Dongen H, de Kroon CD, Jacobi CE, Trimbos JB, Jansen FW. Diagnostic hysteroscopy in abnormal uterine bleeding: a systematic review and meta-analysis. BJOG. 2007 Jun;114(6):664-75. doi: 10.1111/j.1471-0528.2007.01326.x. | |
| 10648742 | Result | De Iaco P, Marabini A, Stefanetti M, Del Vecchio C, Bovicelli L. Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc. 2000 Feb;7(1):71-5. doi: 10.1016/s1074-3804(00)80012-2. |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Lidocaine pump spray |
| Drug |
|
|
| Placebo (for Misoprostol) | Drug | Lactose filler, the pharmacy-produced pills identical to original misoprostol pill |
|
| Placebo (for Lidocaine) | Drug | The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray |
|
| 19243750 | Result | Mulayim B, Celik NY, Onalan G, Bagis T, Zeyneloglu HB. Sublingual misoprostol for cervical ripening before diagnostic hysteroscopy in premenopausal women: a randomized, double blind, placebo-controlled trial. Fertil Steril. 2010 May 1;93(7):2400-4. doi: 10.1016/j.fertnstert.2009.01.073. Epub 2009 Feb 24. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |