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The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (EMLA) | Experimental | 3 mL EMLA® cream 5% will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn. |
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| Group B (Placebo) | Placebo Comparator | 3 mL of ultrasonic gel will be applied in the endocervical canal 7 min before procedure, with a 5-mL needleless syringe. A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA | Drug |
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| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pain experienced during the procedure scored using a VAS. | All women will be asked to score the pain they experienced during the procedure using a VAS that consists of a 10-cm line scaled from 0 to 10 (0 = no pain and 10 = severe pain). Women will be asked to verbally specify the number that represented their level of perceived pain intensity during the hysteroscopy immediately after the procedure. After completing the hysteroscopy, women will be asked if they would recommend the procedure to other women, if they had wished to abandon the hysteroscopy, and whether they would repeat the procedure if needed. | Procedure |
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Inclusion Criteria:
Exclusion Criteria:
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