Investigating the Impact of Formal Interventions on Reducing Residual Opioids in the Home Following Legitimate Prescribing for Acute Post-surgical Pain in Pediatric Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Assess participation in medication take back through follow up phone interview questionnaire.
研究概览
简要总结
The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.
详细描述
Prescription opioids are abused by an estimated 12.5 million Americans, and accidental opioid overdose is the leading cause of injury death in the US. Many of these drugs originate from leftover prescription opioids related to postoperative overprescribing, lack of proper disposal, and unsafe home storage. Governmental guidelines indicate that leftover prescription opioids should be preferentially returned to a drug take back site; however, many people do not utilize these programs due to travel distance, lack of transportation, or other factors.
The aims are to quantify the amount of unused opioids in the home following painful pediatric surgical procedures, investigate the impact of formal interventions on disposal of residual opioids in the home following these surgeries, and to identify current behaviors of adolescents and their family members in the handling of unused prescribed opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Following patient enrollment, only the unblinded study coordinators will provide information and education to the patients/families about which arm they are randomized to. The investigator and other collaborators will conduct follow-up phone calls and data input and analysis in a blinded fashion.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female children ages 12-17.9 years old
- •ASA physical status 1 and 2
- •Patients undergoing primary posterior spinal fusion surgery for correction of idiopathic scoliosis.
- •Patients undergoing Nuss bar correction of pectus excavatum deformity.
排除标准
- •Oxycodone allergy
- •severe sleep apnea
- •developmental delay
- •neurological disorders
- •liver disease/impairment
- •renal disease/decreased renal function
- •patients on opioid therapy prior to surgery
- •Requires a translator for communication in English
研究组 & 干预措施
Control
Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol. There will be no interventions provided. They will receive a follow up phone call survey and be asked to return a completed medication education calendar that is provided as a part of usual APS care.
Medication take back education intervention
Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive a standardized education intervention. This intervention will educate patients and their families about medication take back programs, and will provide tailored directions to the closest medication take back center from their home, and also an option for medication take back that is located in close proximity to Riley Hospital clinics.
干预措施: Medication take back (Other)
Home disposal kit intervention
Patients in this group will receive usual care from the acute pain medicine service, and will go home with standardized multimodal analgesic protocol as described in the control group. They will receive standardized education about how to use the medication home disposal kit : Dispose Rx(r), and they will be instructed to use this kit to dispose of any left over opioid medications that they may have after they have competed therapy for pain management at home.
干预措施: Medication home disposal (Other)
结局指标
主要结局
Assess participation in medication take back through follow up phone interview questionnaire.
时间窗: Post-discharge days 8-10
Assess the degree of participation in medication take back programs to dispose of any residual opioid medications following completion of analgesic therapy.
Assess participation in medication home disposal through follow up phone interview questionnaire.
时间窗: Post-discharge days 8-10
Assess the degree of participation in medication home disposal to dispose of any residual opioid medications following completion of analgesic therapy.
Quantification of residual opioids.
时间窗: Post-discharge days 8-10
Identify if there are left over opioid medications following completion of analgesic therapy, and if so, how many?
次要结局
- Identify noncompliance/unsafe behaviors that contribute to retention of residual opioids through follow up phone interview questionnaire.(Post-discharge days 8-10)
- Frequency of opioid consumption through follow up phone interview questionnaire.(Post-operative day 1 through post-discharge day 10)
- Average daily pain scores reported as values on Numerical Rating Scale.(Preoperatively through post-discharge day #10)