Nexplanon Removal: Subcutaneous vs. Topical Lidocaine
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- pain of procedure
研究概览
简要总结
A randomized trial of using EMLA cream for anesthesia to remove Nexplanon versus the standard route of subcutaneous lidocaine for anesthesia. Primary endpoints are pain during procedure and time to removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Females with Nexplanon implant in place, desiring removal No allergy to lidocaine or any component of EMLA cream Age greater than or equal to 18years English as primary language Not pregnant
排除标准
- •pregnant non-emglish speaking age less than 18 yo Allergy to lidocaine or EMLA
研究组 & 干预措施
EMLA
Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.
干预措施: Eutectic Lidocaine Prilocaine (Drug)
Subcutaneous Lidocaine
Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected at the removal site and then undergo Nexplanon removal.
干预措施: Subcutaneous Lidocaine (Drug)
结局指标
主要结局
pain of procedure
时间窗: during procedure
Using the pain scale the participant is asked to circle the numerical value of pain they had during removal.
time to perform procedure
时间窗: procedure
the medical assistant times the procedure from incision to removal of the device.
次要结局
- How likely to recommend their anesthetic?(procedure)
- Provider's sense of ease of removal?(procedure)
研究者
Manish Jain
Associate Professor, Dept. of Obstetrics and Gynecology
Augusta University