Comparison of Outcomes When Patients Receive Preoperative IV Acetaminophen Versus Preoperative Oral Acetaminophen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Patient Reported Pain
研究概览
简要总结
The current study proposes to examine whether there is a significant difference in patient outcomes related to the administration route of preoperative Acetaminophen. Specifically, the study will compare outcomes of surgical patients who receive IV Acetaminophen with surgical patients who receive oral Acetaminophen.
详细描述
This study will use a randomized, double-blind, controlled design with two arms:
Arm 1: Scheduled IV Acetaminophen and PO placebo provided preoperatively Arm 2: Scheduled PO Acetaminophen and IV placebo provided preoperatively
120 patients will be randomized 1:1 into Arm 1 or Arm 2. All other care, except route of preoperative Acetaminophen, will follow standard care procedures. The following outcome measures will be collected: postoperative pain, postoperative opioid medication administration, postoperative nausea and vomiting, occurrence of respiratory depression postoperatively, occurrence of administration of reversal agent postoperatively, length of stay in recovery room, patient satisfaction with pain control.
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)
盲法说明
Only pharmacy staff will have randomization scheme and be aware of whether patient received oral Acetaminophen with IV placebo OR if the patient received IV Acetaminophen with oral placebo
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
- •18 years old or older
- •Admitted to Bethesda Butler Main Perioperative Services for an outpatient surgical procedure performed under general anesthesia
排除标准
- •Allergy to Acetaminophen
- •Lactose intolerance or lactose allergy (placebo capsules contain lactose)
- •Hepatic disease
- •Having taken a product containing acetaminophen within 6 hours of scheduled surgery time
- •Weight less than 50kg
- •Opioid addiction - admits to current opioid addiction and/or substance abuse disorder, and/or currently in treatment for opioid addiction or substance abuse
- •Emergent or on-call procedures
- •Inpatient surgery
研究组 & 干预措施
Arm 1: IV Acetaminophen group
Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
干预措施: IV Acetaminophen (Drug)
Arm 1: IV Acetaminophen group
Patients randomized to Arm 1 will receive IV Acetaminophen 1000mg in 100mL NS once and a PO placebo pill preoperatively
干预措施: PO Placebo (Drug)
Arm 2: PO Acetaminophen group
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
干预措施: PO Acetaminophen (Drug)
Arm 2: PO Acetaminophen group
Patients randomized to Arm 2 will receive IV normal saline 100mL once and Acetaminophen 1000 mg PO once preoperatively
干预措施: IV Solution Placebo (Drug)
结局指标
主要结局
Patient Reported Pain
时间窗: through study visit, less than 24 hours
Pain measured from 0 (no pain) to 10 (worst pain)
次要结局
- Length of Stay(through study visit, less than 24 hours)
- Number of Participants Who Experienced Postoperative Nausea and Vomiting(through study visit, less than 24 hours)
- Patient Satisfaction(up to 2 days after surgery)
- Number of Participants Who Received Opioid Administration in PACU(through study visit, less than 24 hours)