Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain Scores Using the VAS Questionnaire
研究概览
简要总结
The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.
排除标准
- •Currently pregnant or actively attempting to conceive
- •Those deemed mentally impaired to make their own medical decisions
- •Previous documented allergy to dexamethasone
- •Those currently taking daily steroids for any reason
- •Those with diabetes or deemed to be pre-diabetic
- •Those with contraindications for angiography
- •Prisoners
研究组 & 干预措施
Dexamethasone Arm
A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.
干预措施: Dexamethasone (Drug)
Saline Arm
A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization.
干预措施: Saline (Drug)
结局指标
主要结局
Pain Scores Using the VAS Questionnaire
时间窗: Day 7
Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain).
次要结局
- Severity of Post-embolization Syndrome Symptoms(Day 7)
- Change in Symptoms(Baseline, 3 months)
- Change in Quality of Life(Baseline, 3 months)
研究者
Prasoon Mohan
Associate Professor
University of Miami