A Randomized Controlled Trial to Improve Discharge Opioid Prescribing After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 190
- 试验地点
- 2
- 主要终点
- Unused Opioids
研究概览
简要总结
The number of opioid overdose deaths in the United States has quadrupled in 15 years, a dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp increase in the amount of legal prescription opioids dispensed. The abundance of prescription opioids available is a primary pathway for opioid abuse and diversion. Adjusting post- cesarean delivery opioid prescribing practices to better match actual patient need has the potential to reduce unused opioids available for diversion, nonmedical use, and development of chronic dependence, as well as reduce wasted resources.
详细描述
Preliminary data from a quality improvement project performed in our department found that most women are prescribed opioids after discharge that were significantly in excess of the actual opioids used. However there is a subset of women (~25%) who use all opioids and complain that they were not prescribed enough. The only variable predictive of post- discharge opioid use was Inpatient opioid use. These data were used to develop a formula for estimating outpatient use based on inpatient use. Currently there are no guidelines for outpatient prescribing either at our institution or on a national level. On average, most patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying providers, very few looked at inpatient use and most had a standard prescription that they gave everyone.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 18-50 years old
- •Women undergoing cesarean delivery at a single institution
排除标准
- •Major post-surgical complications: cesarean hysterectomy, bowl or bladder injury, reoperation, ICU admission, wound infection or separation
- •Chronic opioid use: Taking buprenorphine during pregnancy, taking an opioid for > 7 days during pregnancy.
- •Non English or Spanish speaking
研究组 & 干预措施
Tailored
Participants will be prescribed an opioid based on a formula derived from inpatient opioid use
干预措施: Tailored prescription (Other)
Control
Participants will be prescribed 30 tablets of oxycodone 5mg, which is the average prescription currently given to our population.
干预措施: Control (Other)
结局指标
主要结局
Unused Opioids
时间窗: 4 weeks postpartum
oxycodone 5mg tablet leftover from prescription at discharge
次要结局
- Pain: Frequency That Participants Reported Uncontrolled Pain(4 weeks postpartum)
研究者
Sarah Osmundson
Assistant Professor
Vanderbilt University Medical Center