A Prospective, Randomized, Double-blind Study Assessing the Efficacy of Intravenous (IV) Ibuprofen Versus IV Acetaminophen for the Treatment of Pain Following Orthopaedic Low Extremity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
This study aims to evaluate the efficacy of IV Ibuprofen versus IV Acetaminophen in the reduction of pain following orthopedic low extremity procedures
详细描述
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Patients undergoing orthopedic low extremity surgery were screened. Eligible subjects were then randomized into treatment group (intravenous ibuprofen) and control group (intravenous acetaminophen). In case required, patients from both group will be given Morphine (PCA) 1-2 mg every 5 minutes.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for Orthopedic Low Extremity Surgery with general anesthesia and anticipated need post operative IV analgesia with anticipated use of >48 hours.
- •Adequate IV access.
- •Anticipated hospital stay>48 hours.
- •Age 18-70 years old with physical status ASA I- III.
- •Patients able to fill informed consent sheet.
排除标准
- •patients with use of analgesia, muscle relaxants, NSAIDs and sedatives less than 24 hours to study drug administration
- •anemia (active, clinically significant anemia) and/or a history or evidence of asthma or heart failure
- •historical or at higher risk intracerebral bleeding, history of allergy or hypersensitive to NSAID, Ibuprofen, Acetaminophen or opioid
- •pregnant or nursing
- •body weight less than 30 kg
- •any active clinically significant bleeding or have underlying platelet dysfunction and/or receiving full dose anticoagulation therapy
- •GI bleeding that required medical intervention within the previous 6 weeks (unless definitive surgery has been performed)
- •on dialysis or renal dysfunction
- •impaired liver function
- •inability to achieve hemostasis or inability to close surgical incision prior to operating room discharge
- •operative procedure includes organ transplant, pre-and intra- operative procedure utilized for the prevention of pre- or post-operative pain (i.e, epidural or nerve blocks)
- •received anoher investigational drug within the past 30 days
- •known or suspected history of alcohol or drug abuse
- •severe infection and/or inflammatory disease
研究组 & 干预措施
Ibuprofen group
800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
干预措施: Ibuprofen (Drug)
Acetaminophen group
1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Pain intensity
时间窗: 24 hours
demonstrated by the measurement VAS (Visual Analog Scale) for 24 hrs postoperative.
次要结局
未报告次要终点
研究者
Aida Rosita Tantri
Principal Investigator
Indonesia University