The Impact of Ohio's Opioid Prescriptions Law on Opioid Use and Outcomes in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 1
- 主要终点
- Change in opioid prescriptions
研究概览
简要总结
The legitimate need for opioid medications for acute pain management in pediatric trauma patients is recognized, however, the high dose and duration of opioid drugs prescribed by medical providers has been associated with an increased risk of opioid abuse and chronic use by patients. The overarching goal of application is to assess opioid use and outcomes of pediatric patients treated for either burn injuries or knee arthroscopy procedures at a large academic pediatric medical center before and after Ohio opioid prescription rules for acute pain were implemented on August 21, 2017. Also, to evaluate patient use of opioids at 90-days post-treatment.
详细描述
This study has a prospective and retrospective component. Phase 1 involves a retrospective chart review will be performed among pediatric patients undergoing burn care or knee arthroscopy at our institution to determine a whether there was a reduction in prescribed opioid medications following the 2017 Ohio opioid prescription law. A 24-month pre-law period (August 1st, 2015, to August 31st, 2017) and 24-month post-law period (September 1st, 2017, to August 31st 2019) will be compared. This phase will include 300 patients (n=150 burn, n=150 knee arthroscopy) evenly divided between the pre-law and post-law periods.
Phase 2 involves a prospective patient telephone survey 90 days after burn care or knee arthroscopy procedure to assess the association of opioid prescribing, consumption and amount of left-over medications, and pain control status after 90 days. This phase will include 100 patients (n=50 burn, n=50 knee arthroscopy) recruited via convenience sampling.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric patients age 0-18 years (inclusive)
- •treated at our institution for either a burn injury or knee arthroscopy procedure
- •received at least one opioid prescription
排除标准
- •patients age 19 years and above
- •patients who did not receive any opioid medications
- •patients undergoing knee arthroscopy with simultaneous anterior cruciate ligament (ACL) reconstruction
- •families unable to to communicate in English
结局指标
主要结局
Change in opioid prescriptions
时间窗: 2 years before and 2 years after Ohio opioid law
Change in opioid medications prescribed pre-law and post-law (reported in morphine equivalent doses)
Long-term opioid use
时间窗: 90 days post treatment
Patients using opioid medications 90-days post treatment
次要结局
- Comparison of opioid medications usage(2 years before and 2 years after Ohio opioid law)
研究者
Henry Xiang
Professor and Center Director
Nationwide Children's Hospital