Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Pain during uterine aspiration
研究概览
简要总结
Intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. The investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. The investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Seeking office based uterine aspiration
- •Gestational age at 14 weeks or less
- •Age 14 years or older with parental consent to participate in this research study if 14-17 years old
- •Able to read, speak, and understand English
- •Ability to understand materials and consent forms
排除标准
- •Seeking medical abortion, operating room based surgical abortion, or operating room based miscarriage management
- •Gestational age greater than 14 weeks
- •Age less than 14 years old
- •Inability to read, speak, and understand English
- •Current incarceration
- •Weight less than 40kg
- •Self-reported or documentation of significant cardiopulmonary disease
- •Self-reported or documentation of alcohol or substance dependence or abuse
- •Contraindications, relative contraindication to fentanyl use
研究组 & 干预措施
Fentanyl
干预措施: Fentanyl (Drug)
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Pain during uterine aspiration
时间窗: During uterine aspiration or immediately after uterine aspiration
Self reported on 100 mm VAS
次要结局
- Post-procedural pain(approximately 15 minutes after procedure end)
- Patient satisfaction with procedural pain control(approximately 15 minutes after procedure ends)