Quantity of Opioids for Acute Pain and Limit Unused Medication (OPUM Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,240
- 试验地点
- 6
- 主要终点
- Quantity of opioids consumed during the acute pain phase (2 weeks) following ED discharge for each pain condition
研究概览
简要总结
Opioids (morphine and morphine-like substances) are often prescribed to patients to manage pain after an emergency department visit. In the past 20 years, opioid prescriptions have risen sharply, accompanied by a significant rise in opioid misuse (e.g., recreational or non-medical use, potentially leading to addiction or overdose). One explanation for this crisis is the availability and easy access of leftover opioid pills in Canadian homes, allowing family members (including children) and friends to take them for reasons other than pain relief.
Canada has no recommendations for the dosage, duration, or quantity of opioids that physicians should prescribe to manage acute pain at home. Physicians are therefore left guessing as to how much to prescribe when a patient with a condition like a fracture or renal colic is discharged from the emergency department. Our preliminary study showed that two-thirds of the pills from the initial opioid prescription to treat acute pain actually remained unused and were therefore available for potential misuse.
The investigators propose to determine how many opioid pills are consumed by patients who suffer from acute pain as they recover at home. The investigators will ask 2,560 patients (from 6 Canadian hospitals) to record their pain medication consumption in a 14-day diary. The investigators will also determine, their pain intensity level, whether or not they had new opioid prescriptions, and health services revisits. In case of missing information, patients will be contacted by phone at 2 weeks. The overall aim is to help emergency department physicians prescribe the right number of pills in order to manage patients' pain and at the same time reduce substantially leftovers available for potential misuse.
详细描述
Introduction
Prescription opioid overdoses have quadrupled in the last 15 years, and are now the leading cause of accidental death, surpassing motor vehicle accidents. The drastic rise in opioid prescription rates in Canada and the US could be the driving force behind this higher mortality. It was shown that 71% of opioid misusers (i.e., intentional users for nonmedical purposes) received their drugs through the diversion of unused prescribed opioids (transfer of opioids to someone other than the holder of the initial prescription). Emergency department (ED) physicians are among the top opioid prescribers for patients under 40, and there are currently no prospective studies on how many opioid pills should be prescribed to patients discharged from the ED with common pain conditions in order to limit unused pills. Preliminary results from our group revealed that two-thirds of the total prescribed opioids were not consumed and remained available for misuse.
Objectives
The ultimate goal of this research program is to decrease opioid misuse by lowering the quantity of unused medications. The primary objective of this project is to determine the quantity of opioids consumed during the acute pain phase (2 weeks) by ED-discharged patients treated for an acute pain condition. The secondary objectives are to inventory the quantity of opioids prescribed and unused after ED visits, use of co-analgesics, pain intensity, health services revisits during the 2-week follow-up, and chronic pain prevalence at 3 months.
Methods
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Opioid prescription at discharge
- •Acute pain for less than 2 weeks
排除标准
- •Language barrier
- •Chronic pain under treatment
- •Active Neoplasia
- •Follow-up impossible / Unable to complete agenda
- •Already on opioids
结局指标
主要结局
Quantity of opioids consumed during the acute pain phase (2 weeks) following ED discharge for each pain condition
时间窗: During 14 days
This will allow us to define the quantity of opioids needed to manage acute pain while limiting the quantity of unused pills available for potential misuse.
次要结局
- Quantitive validation of the patients' self-report opioid consumption(At day 14)
- Group-based trajectory modeling to determine pain intensity trajectory for each pain condition during the acute phase(During 14 days)
- Quantity of unused opioids(At day 14)
- Quantity of patients who revisit health services to obtain new prescription(During 14 days)
- Evaluate the chronic pain prevalence at 3 months among study participants assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later.(3 months)
- Quantity of opioids to sufficiently supply a given percentage of patients for each pain condition(During 14 days)
- Incidence and type of medication side effects during the 2-week period(During 14 days)
- Quantity of opioids prescribed to ED-discharged patients treated for different acute pain conditions(Baseline)
- Quantity of patients that filled (initial or other) opioid prescriptions(At day 14)
- Quantity of patients using of coanalgesics or other substances (alcohol, cannabis…) to manage pain(During 14 days)
- Qualitative evaluation of the participants' reasons for stopping opioid consumption(During 14 days)
- Assessed if certain profiles of pain intensity evolution over the14-day after emergency department (ED) discharge are predictive of chronic pain 3 months later(3 months)
研究者
Raoul Daoust
Clinician Researcher
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal