NCT03545893已完成4 期
A Pilot Randomized Trial of Opioids Versus Nonopioids for Pain Control After Osmotic Dilator Placement for Abortion Care
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Maximum Pain Score
研究概览
简要总结
The purpose of this study is to compare maximum pain scores between patients seeking induced abortion and requiring cervical preparation with osmotic dilators. Patients will be randomized to receive prescription for ibuprofen alone or to receive prescription for ibuprofen + oxycodone for overnight pain management after cervical preparation with osmotic dilators. Data collected in-person and through a text-messaging platform.
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
- 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
- 否
入选标准
- •English-speaking women
- •18 years or older
- •Access to cell phone with text-messaging capability/data
- •Receiving cervical preparation for induced abortion
- •Able to complete baseline survey on smartphone/tablet at screening visit
排除标准
- •History of opioid or alcohol abuse
- •Contraindications or allergy to ibuprofen
- •Contraindications or allergy opioid medications
- •Seeking uterine evacuation for premature preterm rupture of membranes or advanced - cervical dilation or intrauterine fetal demise
研究组 & 干预措施
Ibuprofen
Active Comparator
干预措施: Ibuprofen 600 mg (Drug)
Ibuprofen + Oxycodone
Active Comparator
干预措施: Ibuprofen 600 mg (Drug)
Ibuprofen + Oxycodone
Active Comparator
干预措施: OxyCODONE 5 Mg Oral Tablet (Drug)
结局指标
主要结局
Maximum Pain Score
时间窗: 24 hours
Numerical Rating Scale (NRS) pain score (scale range 0-10, with a 0 meaning "no pain" and 10 meaning the "worst possible pain")
次要结局
未报告次要终点
研究者
研究点 (1)
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