Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cumulative Opioid Consumption
研究概览
简要总结
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Males or females 18 years of age or older.
- •Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.
排除标准
- •Redo cardiac surgery.
- •Combined CABG (Coronary Artery Bypass Graft)& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
- •Weight < 50 Kg or Body mass index > 38 kg/m
- •Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction.
- •Severe (3-4 +) Tricuspid Regurgitation.
- •Recent stroke (within 6 months).
- •Severe lung disease requiring home O2 therapy.
- •Preoperative renal insufficiency (Creatinine > 2.0) or on dialysis.
- •History of liver cirrhosis or active liver disease.
- •Chronic pain conditions controlled by preoperative opioid administration.
- •Known allergy to acetaminophen or fentanyl.
研究组 & 干预措施
IV Acetaminophen
Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
干预措施: IV Acetaminophen (Drug)
Placebo
Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative Opioid Consumption
时间窗: End of surgery through 24 hours after surgery
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption a after cardiac surgery. Total opioid consumption is defined as the total amount amount of opioids administered to patients converted to mg morphine equivalents.
Pain Intensity
时间窗: End of surgery through 24 hours after surgery
Evaluate the noninferiority and efficacy of IV acetaminophen; compared to a placebo, in reducing pain intensity scores after cardiac surgery. Pain scores were measured on the Numeric Rating scale, ranging from 0 to 10 (where 0 indicates no pain and 10 indicates the worst pain imaginable).
次要结局
- Total Bilirubin (mg/dL)(Measured at 1 day and 2 days after surgery)
- Postoperative Nausea and Vomiting(End of surgery through 24 hours after surgery)
- Postoperative Sedation(Measured at 8, 16, and 24 hours after surgery)
- Duration of Mechanical Ventilation (Minutes)(End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.)
- Intensive Care Unit (ICU) Length of Stay(End of surgery through discharge from ICU)
- Hospital Length of Stay(end of surgery through hospital discharge)
- Alanine Aminotransferase (ALT); U/L(Two days after surgery or date of death from any cause, whichever came first)
- Aspartate Aminotransferase (AST); U/L(Two days after surgery or date of death from any cause, whichever came first)