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临床试验/NCT03694899
NCT03694899已完成不适用

The Excess Opioid Disposal Study

Dartmouth-Hitchcock Medical Center2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
2
主要终点
opioid disposal rate

研究概览

简要总结

This study is designed to test the hypothesis that providing information to patients about excess opioid disposal, calling patients prior to their outpatient post-operative surgical appointment and providing a convenient drop box for opioid disposal will increase rates of FDA compliant disposal.

详细描述

It is hypothesized that:

  1. By providing pre-operative patient education, a drop-box in a convenient location (the hospital pharmacy near the surgical outpatient clinic) and a reminder phone call prior to the post-operative clinic appointment, an increase in FDA-compliant unused opioid disposal rates to at least 40% will be seen.
  2. The investigator's guideline for opioid prescribing after operations that require an inpatient admission which the investigator established for general surgical procedures will satisfy the opioid requirements of at least 85% of patients undergoing a variety of operations from differing specialties.
  3. The utilization of guideline opioid prescribing and FDA-compliant unused opioid disposal will decrease the percentage of patients who are taking opioids at 6 months and 1 year after their surgery to less than 1%.

The primary objective is to determine the effect of pre-operative patient education, a drop-box in the hospital pharmacy and a reminder phone call on the proportion of patients who dispose of unused opioids using a FDA-compliant method.

Secondary objectives include:

  1. Determine in a prospective study whether our guideline for opioid prescribing after surgery which requires inpatient admission fulfills the opioid requirements of at least 85% of patients undergoing a variety of operations.
  2. Determining the effect of guideline opioid prescribing and FDA-compliant unused opioid disposal on the proportion of patients who are on opioids 6 months and 1 year after their surgery.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Having surgery with expected duration of admission of 2 days or more

排除标准

  • Allergies to opioids
  • Allergy or contra-indication to short term acetaminophen or ibuprofen
  • Chronic opioid use
  • History of opioid abuse

结局指标

主要结局

opioid disposal rate

时间窗: 1 year

% of patients that dispose of excess opioids in an FDA compliant manner

次要结局

  • Does guideline predict opioid needs(6 months)
  • effect on long term opioid usage(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Richard J. Barth,Jr.

Chief, Section of General Surgery

Dartmouth-Hitchcock Medical Center

研究点 (2)

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