A Randomized Clinical Trial Comparing Oral Conscious Sedation With Intravenous Conscious Sedation for First Trimester Surgical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Pain scale
研究概览
简要总结
The main objective of this study is to determine the equivalency of oral conscious sedation and intravenous conscious sedation for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation for pain control. Additional objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.
详细描述
The main objective of this study is to determine the equivalency of oral conscious sedation (oxycodone 10mg PO plus lorazepam 1mg SL) and intravenous conscious sedation (fentanyl 100 µg plus midazolam 2mg) for first trimester surgical abortion. We hypothesize that oral conscious sedation will be equivalent to intravenous conscious sedation as defined by ± 1 point on a 21-point pain scale. Subsidiary objectives include describing subject satisfaction with each method of pain control and characteristics of each method such as side effect profile, recovery room time, and postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age 18 or older.
- •Undesired pregnancy between 6 0/7-12 6/7 weeks gestation.
- •Has already signed consent for pregnancy termination.
- •Eligible for IV sedation per clinic protocol.
排除标准
- •Under 120 lbs.
- •Allergies to any of the drugs being studied.
- •Chronic narcotics, barbiturates or benzodiazepine use within the past year.
- •History of IV drug use within the last year.
- •Inability to give informed consent.
- •Does not speak English or Spanish and does not have translator for all study procedures
- •Previously participated in study
结局指标
主要结局
Pain scale
次要结局
- Measures of satisfaction, side effects, recovery time