Randomized Control Trial of IV Acetaminophen for Post Cesarean Delivery Pain Relief
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Total Oxycodone (mg)
研究概览
简要总结
This study is being done to evaluate the scheduled use of intravenous (IV) acetaminophen among cesarean section patients. The study hopes to find out if patients who receive scheduled IV acetaminophen for 48 hours following delivery have lower self-reported pain scores and use less narcotic pain medication than patients who do not receive IV acetaminophen.
详细描述
See Brief Summary
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years
- •Scheduled cesarean section delivery
- •Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
- •Singleton pregnancy
- •Term delivery (greater than or equal to 37 weeks)
- •Spinal/epidural anesthesia with epidural analgesia (duramorph)
- •Use of pfannenstiel incision
排除标准
- •Weight less than 50 kg
- •Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
- •Multiple gestation pregnancy
- •Cesarean section for pre-term delivery (less than 37 weeks)
- •Fetal anomalies
- •Inability to use epidural duramorph at time of procedure
- •General anesthesia used
- •Vertical skin incision
- •Opioid addiction
- •Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)
研究组 & 干预措施
IV Acetaminophen
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
干预措施: IV Acetaminophen (Drug)
Normal Saline
Subjects will receive a 100mL dose of saline every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
干预措施: Placebo (Drug)
结局指标
主要结局
Total Oxycodone (mg)
时间窗: approximately 2 - 7 days
Total oxycodone (mg) for breakthrough pain during inpatient stay
次要结局
- Number of Participants With Narcotic Associated Side Effects(2-7 days)
- Length of Stay(2-7 days)