Intravenous Acetaminophen for Craniotomy Patients: A Single-blinded, Randomized Controlled Trial to Evaluate the Effect of Intravenous Acetaminophen Administered at Induction and Emergence From Craniotomy
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total narcotic dose administered over the first 12 hours of postoperative recovery.
研究概览
简要总结
Adding intraoperative IV acetaminophen, in addition to standard analgesics, will decrease opioid requirements over the first 12 hours of postoperative recovery following craniotomy. Opioids exacerbate symptoms of nausea and vomiting. Reducing postoperative opioid use hopefully will reduce incidence of nausea and vomiting in patients after craniotomy.
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
- Single (Participant)
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
- •At least 18 years of age
- •Weigh at least 50 kg (110.23 lbs)
- •Undergoing open, elective intracranial procedure for
- •tumor resection
- •aneurysm clipping
- •revascularization
- •Have an ASA (American Society of Anesthesiologists) physical status of 1, 2, 3, or 4
- •Able to provide written informed consent
排除标准
- •Significant medical disease, laboratory abnormality, or condition that, in the opinion of the investigator, would compromise patient welfare or would otherwise contraindicate study participation
- •Unable to communicate symptoms
- •Current daily opioid use (>40 mg morphine equivalent)
- •Tramadol use
- •Treated with MAO (monoamine oxidase inhibitors) inhibitors within 10 days of surgery
- •Treated with any amount of acetaminophen within 8 hours of anesthesia for surgery
- •Allergic or hypersensitive to acetaminophen or any contraindications per manufacturer's guidelines
- •Pregnancy
- •Impaired liver function
- •Participation in interventional clinical study within the last 30 days
- •Known or suspected history of alcohol or drug abuse
- •Surgery for resection of acoustic neuroma
- •Transphenoidal tumor resection
研究组 & 干预措施
Acetaminophen
Craniotomy patients will receive a 1000 mg dose of intravenous (IV) acetaminophen before incision and a second 1000 mg dose of IV acetaminophen 6 hours later.
干预措施: Acetaminophen (Drug)
结局指标
主要结局
Total narcotic dose administered over the first 12 hours of postoperative recovery.
时间窗: 12 hours
Intensive care nurses will ask subject about pain and nausea every 15 minutes for the first two hours immediately after surgery and then every hour afterward for up to 12 hours. Nurses will record subject response and opioid doses given.
次要结局
- Incidence of nausea during postoperative recovery(12 hours)
- Incidence of vomiting during postoperative recovery(12 hours)
- Severity of nausea during postoperative recovery(12 hours)
- Severity of vomiting during postoperative recovery(12 hours)