Assessment of the Analgesic Efficacy of Intravenous Ibuprofen in Biliary Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Pain Score 120 Minutes After Study Medication Administration
研究概览
简要总结
The aim of this study is to assess the analgesic efficacy of intravenous ibuprofen given in the Emergency Department for the treatment of biliary colic. We hypothesize that intravenous ibuprofen will provide a clinically significant drop in self-reported patient pain level as measured by the visual analog scale.
详细描述
It is estimated over 20 million people aged 20-74 have gallbladder disease, with biliary colic being a common and painful symptom in these patients. Likely due to the relatively recent approval of intravenous ibuprofen use for fever and pain in adults, no assessment of its analgesic efficacy for biliary colic currently exists in the literature.
Utilizing a visual analog scale (VAS) for patient self-assessment of pain, this study will address this lack of evidence and identify intravenous ibuprofen's value as a novel analgesic in the treatment of biliary colic. Patients will be given a VAS at the time of study therapy administration, at 15-minute intervals during the first hour post-administration, and 30-minute intervals in the second hour. Though NSAID's have been extensively studied in the management of this phenomenon, this study aims to help optimize pain treatment of patients presenting to the Emergency Department with biliary colic, and potentially pave the way for future analgesic treatment comparison studies.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 18-55
- •Present to ED with right upper quadrant (RUQ) abdominal pain
- •Suspected diagnosis of biliary colic
- •Negative pregnancy test for women of childbearing potential (complete POC testing form)
- •No history of cholecystectomy
排除标准
- •Patient age < 18 or > 55
- •Incarcerated
- •Hemodynamic instability
- •Inability to reliably self-report or communicate pain intensity and pain relief
- •Taking Warfarin
- •Cannot consent of are not competent to consent
- •Hepatic, renal, cardiac failure
- •NSAID or morphine allergy
- •History congenital bleeding diathesis or platelet dysfunction
- •Peptic ulcer diseases
- •Are otherwise unsuitable for the study in the opinion of the investigator/sub-investigators
研究组 & 干预措施
Control Group: Adults age 18-55 years
Saline-only control group
干预措施: Saline (Drug)
IV Ibuprofen: Adults age 18-55 years
Patients receiving intravenous ibuprofen therapy
干预措施: IV Ibuprofen (Drug)
结局指标
主要结局
Pain Score 120 Minutes After Study Medication Administration
时间窗: 120 minutes post medication administration
Pain is measured on a visual analog scale 0=no pain and 10=worst pain imaginable.
次要结局
未报告次要终点