Nitrous Oxide Versus Intravenous Sedation for Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) Score for Maximum Procedural Pain
研究概览
简要总结
This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl and midazolam, for pain management in adult women having a pregnancy termination procedure between 12 and 16 weeks gestational age.
详细描述
This study will evaluate whether nitrous oxide is a feasible and acceptable alternative to IV sedation for pain management during early second trimester D&E. Primary endpoints will include maximum procedural pain using the visual analog scale (VAS) as well as satisfaction with anesthesia using the Iowa Satisfaction with Anesthesia Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, 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
- •18 years old or older
- •pregnancy termination at gestational age of 12-16 weeks
- •able to read and understand either English or Spanish
- •able to obtain reliable post-procedure transportation
排除标准
- •contraindications to outpatient pregnancy termination
- •contraindications to nitrous oxide use (such as pernicious anemia, current treatment with bleomycin chemotherapy, active upper respiratory illness, or COPD)
- •intrauterine fetal demise
- •chronic narcotic use
- •known adverse reaction to nitrous oxide, Fentanyl, or Versed
研究组 & 干预措施
Nitrous oxide and IV saline
Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
干预措施: Nitrous Oxide (Drug)
Nitrous oxide and IV saline
Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
干预措施: IV Saline (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Score for Maximum Procedural Pain
时间窗: Assessed immediately following completion of the procedure (as defined as removal of the speculum)
To compare women's maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.
Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])
时间窗: Assessed 30 minutes after procedure completion.
The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).
次要结局
未报告次要终点
研究者
Rameet Singh
Chief, Division of Family Planning
University of New Mexico