Lidocaine-Prilocaine Cream as Analgesic for Outpatient Gynecological Procedures; A Randomized-Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale Pain Score 3
研究概览
简要总结
The goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: Intra Uterine Device (IUD) insertion, hysteroscopy, and endometrial biopsy and given either Eutectic Mixture of Local Anesthetics (EMLA) cream or a placebo. The main question to answer is:
• Does EMLA cream reduce pain when administered during the following gynecological procedures: IUD insertion, hysteroscopy, and endometrial biopsy?
Participants will be asked to do assess their pain on the Visual Analogue Scale through 3 times during the procedure. Researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.
详细描述
Gynecologic outpatient procedures such as intra-uterine device (IUD) insertion, hysteroscopy and endometrial biopsies (EMB) have no standard of care for pain management. This has resulted in acute pain for patients. One local anesthetic, Eutectic Mixture of Local Anesthetics (EMLA) cream (Lidocaine 2.5%/Prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and IUD placement when compared to a placebo. The purpose of this study is to evaluate whether EMLA cream reduces pain during the following outpatient procedures: EMB, hysteroscopy, and IUD placement. Through a randomized control double-blind trial, study participants will have either 5 grams of EMLA cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. Patients' intensity of pain will be assessed using the Visual Analogue Scale (VAS) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. Pain scores will be compared between the study and placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies
排除标准
- •Known hypersensitivity to amide anesthetics
- •Pre-existing methemoglobinemia
研究组 & 干预措施
VersaPro Cream
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
干预措施: VersaPro Cream Base for Compounding (Drug)
EMLA Cream
5 grams will be applied to patient's cervix 7 minutes before gynecological procedure
干预措施: EMLA Cream (Drug)
结局指标
主要结局
Visual Analogue Scale Pain Score 3
时间窗: 2 minutes after speculum removal
Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 1
时间窗: At time of speculum placement for procedure
Scale of 0-10 on a self-reported pain score
Visual Analogue Scale Pain Score 2
时间窗: At start of cervical manipulation
Scale of 0-10 on a self-reported pain score
次要结局
未报告次要终点
