Lidocaine-Prilocaine (EMLA®) Cream in Hysteroscopy Practice: A Prospective Randomized Non-blinded Controlled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 184
- 主要终点
- Pain experienced during the procedure scored using a VAS.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients that must perform a diagnostic hysteroscopy.
- •Acceptance to participate in the study.
- •Signed informed consent.
- •Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
- •Absence of sedative use 24 h before admission
排除标准
- •Hypersensitivity or allergy to anesthetics
- •refusal of the patient
- •Patients under age 18 and pregnant.
- •Patients on anti-arrhythmic drugs due to possibility of drug interaction.
- •Unbearable pain that involves other analgesic measures.
- •Allergic reactions to topical anesthetics
研究组 & 干预措施
Group A (EMLA)
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 A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.
干预措施: EMLA (Drug)
Group B (Placebo)
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 A subsequent application will be made with a swab at ectocervix level, using a vaginal speculum, which will be then withdrawn.
干预措施: Placebo (Other)
结局指标
主要结局
Pain experienced during the procedure scored using a VAS.
时间窗: Procedure
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.
次要结局
未报告次要终点
研究者
Hamdy Bakry Mohye Soliman El Kinawy
TA
Ain Shams Maternity Hospital