Treatment of Acute Pancreatitis With Ketorolac
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in C-Reactive Protein (CRP)
研究概览
简要总结
Patients with acute pancreatitis will be randomly assigned in either study group to receive oral (injection) Ketorolac or the control group. In patients who cannot tolerate oral medications, ketorolac injection will be used.
详细描述
Patients with acute pancreatitis will be randomly assigned in either study group or control group.
- The study group will receive injection or oral Ketorolac.
- The control group will receive standard medical treatment.
Ketorolac is administrated three times daily by mouth or injection starting from the time of admission for the first three days of hospitalization (72 hours).
Hs-CRP will be measured in admission in addition to standard laboratory tests.It will be done every day for up to 5 days, after the administration of study drug or till the time of discharge whichever occurs earlier. Patients will follow up for organ failure involvement and duration of hospitalization. The study will continue to gather clinical follow up information up to four months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Predicted Severe Acute Pancreatitis
- •Enrollment within 72 hours of diagnosis
- •Obtaining informed consent
- •Age >18 years
排除标准
- •Heart disease, Hypertension
- •Hemorrhagic diathesis, Incomplete hemostasis, High risk of bleeding
- •Lactating women
- •Advanced renal disease
- •Hypersensitivity to ketorolac, aspirin, other NSAIDs
- •Concurrent use with aspirin, other NSAIDs, probenecid, or pentoxifylline
- •Active or history of peptic ulcer disease
- •Recent or history of GI bleeding or perforation
- •Inflammatory bowel disease
- •Severe hepatic impairment or active hepatic disease
研究组 & 干预措施
Ketorolac
Ketorolac,10 mg, 3 times daily from time of enrollment until 72 hours from enrollment for up to a maximum of 9 doses, along with the standard medical treatment
干预措施: Ketorolac (Drug)
结局指标
主要结局
Change in C-Reactive Protein (CRP)
时间窗: baseline to Day 5
baseline to Day 5
次要结局
- Number Of Subjects With New Onset Organ Failure During Hospitalization(30 days or until dismissal date whichever occurs earlier)
- Number Of Subjects With New Onset Pancreatic Necrosis During Hospitalization(30 days or until dismissal date whichever occurs earlier)
- Mortality(30 days or until dismissal date whichever occurs earlier)
- Duration of hospitalization(30 days or until dismissal date whichever occurs earlier)
- Time of beginning and tolerance to nutrition(30 days or until dismissal date whichever occurs earlier)
研究者
Zahra Vahdat Shariatpanahi
Associated Professor
Ilam University of Medical Sciences