The Use of Intravenous Ketorolac in a Multimodal Approach to Pain Management in Acute Pancreatitis
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Opioid use during study enrollment
研究概览
简要总结
This study will compare pain management strategies for patients hospitalized with acute pancreatitis. Standard of care pain management will be compared to standard of care plus intravenous ketorolac.
详细描述
Patients hospitalized for acute pancreatitis and admitted to an internal medicine team will be eligible for study. Patients enrolled will be blindly randomized to receive open-label pain management of standard of care or standard of care plus intravenous ketorolac. Patients will be enrolled between hour 24 and 48 of hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •18 years old
- •opioid order for pain secondary to acute pancreatitis
- •diagnosis of acute pancreatitis defined by the presence of two of the following three criteria: abdominal pain, lipase > 3x upper limit of normal, and/or findings of AP on imaging
- •a patient with acute-on-chronic pancreatitis that does not exhibit elevated lipase levels is eligible for inclusion if the patient has the other two criteria
- •received at least 3 L of IV crystalloid fluid within first 24 hours of admission to ensure patients have received initial volume expansion
- •hemodynamically stable represented by a mean arterial blood pressure (MAP) of ≥65 mmHg
- •female patients not documented in chart as post-menopause must have a negative pregnancy test
排除标准
- •history of chronic heart failure
- •history of acute coronary syndrome (ST-elevation myocardial infarction (STEMI) or non-ST elevation myocardial infarction (NSTEMI)) within last 6 months
- •history of ischemic or hemorrhagic stroke within last 6 months
- •history of upper gastrointestinal bleed (GI) within last 6 months
- •history of inflammatory bowel disease
- •history of cirrhosis
- •any overt, active bleeding requiring blood transfusion
- •considered to be high bleed risk (platelet < 50,000/mcL)
- •pregnant or breastfeeding
- •prisoners
- •cognitively impaired patients: not alert and oriented to person, place, and time (patient must be able to consent)
- •allergy to NSAIDs, ketorolac, or aspirin
- •admission to an intensive care unit
- •evidence of infected pancreatitis (i.e. abscess) on imaging studies
- •acute kidney injury or chronic kidney disease with CrCl<30
研究组 & 干预措施
Ketorolac
Patients will receive standard of care pain management plus intravenous ketorolac.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Opioid use during study enrollment
时间窗: day 1 to day 5 of study
oral morphine equivalents (OME)
次要结局
- Day-to-day oral morphine equivalents(day 1 to day 5 of study)
- Duration of intravenous opioid use(During hospital admission)
研究者
Anthony Gentene
Clinical Pharmacy Specialist
University of Cincinnati