Comparative Efficacy of Intravenous Acetaminophen vs. Oral Acetaminophen in Ambulatory Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- PACU Visual Analogue Pain Scores
研究概览
简要总结
There is limited research on the clinical outcome differences between intravenous (IV) acetaminophen versus oral (PO) acetaminophen. With the costs of intravenous acetaminophen sometimes being almost 100 times the cost of PO acetaminophen, it is not only important fiscally but also clinically to differentiate the benefits of IV vs PO acetaminophen. The proposed research study is to determine the clinical advantages of IV vs PO acetaminophen during the post-operative recovery time for ambulatory surgery patients by analyzing differences in time to first opioid delivery, pain scores, and patient satisfaction.
详细描述
In previous literature it has been shown that compared to placebo, IV acetaminophen can improve postoperative pain scores and reduce opioid requirements. In addition, IV acetaminophen has several pharmacokinetic properties that may be beneficial when compared to acetaminophen. IV acetaminophen has been shown to achieve a more rapid and higher maximum plasma concentration as well as higher cerebrospinal fluid concentrations. Comparative effectiveness trials of IV vs PO administration have not conclusively demonstrated improved clinical outcomes despite the proposed pharmacokinetic benefits. More research needs to be conducted to determine possible clinical advantages.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA scores I-III
- •Ambulatory surgery patients
- •Ages 18-75
- •Surgeries requiring general anesthesia for hernia surgery
排除标准
- •Patients with contraindications to acetaminophen (history of end organ liver dysfunction)
- •Known allergy to acetaminophen
- •Emergency surgery
- •Patients who were not fasted
- •Patients who cannot tolerate PO
- •Surgery anticipated to last longer than 3 hours or requiring re-dose of acetaminophen
- •Pregnancy
- •Weight less than 50kg
- •Chronic daily narcotic use
- •Patients who's anesthetic plan requires regional anesthesia
- •Patient refusal to participate or do not have capacity to provide consent.
研究组 & 干预措施
Oral Acetaminophen
Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.
干预措施: Oral Acetaminophen (Drug)
Oral Acetaminophen
Patients who are randomized to have oral acetaminophen will take oral acetaminophen preoperatively and receive saline intraoperatively.
干预措施: Saline (Drug)
Acetaminophen IV Soln
Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.
干预措施: Acetaminophen IV Soln (Drug)
Acetaminophen IV Soln
Patients randomized to IV acetaminophen will receive IV acetaminophen after induction of general anesthesia and will take placebo pills preoperatively.
干预措施: Placebo Pills (Drug)
结局指标
主要结局
PACU Visual Analogue Pain Scores
时间窗: baseline, 1 hour, and Day 1 discharge
Post-Anesthesia Care Unity (PACU) pain scores at baseline, 1 hour, and on discharge from PACU. Pain score by visual analogue score, total scale from 0 to 10 with 10 being the worse pain.
Total MME Intraoperatively
时间窗: Day 1
Total Morphine Milligram Equivalent (MME) use intraoperatively
Total Narcotic Use in PACU.
时间窗: Day 1
Total narcotic use in PACU expressed in total morphine milligram equivalents (MME)
次要结局
- PACU Length of Stay(up to 24 hours after PACU arrival)
- Patient Satisfaction.(7 days post surgery)
- Patient Reported Total Narcotic Use Post-discharge(average 7 days)
研究者
Yan Lai
Assistant Professor of Anesthesiology, Perioperative & Pain Medicine
Icahn School of Medicine at Mount Sinai