Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Cumulative Postoperative Opiate Consumption
研究概览
简要总结
This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.
详细描述
This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.
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
- Single (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
- 是
入选标准
- •Parturients 18 years
- •Elective Cesarean delivery
- •Spinal anesthesia
- •Able to consent to the study and participate in the follow-up.
排除标准
- •Weight under 50 kgs
- •Allergy to acetaminophen
- •General anesthesia
- •Urgent or emergent cases
- •Bleeding diathesis or other coagulopathy
- •G6PD deficiency
- •Liver disease
- •Substance abuse or dependence
- •HELLP syndrome
- •Thrombocytopenia or platelet dysfunction
- •History or active gastrointestinal bleeding
- •Acute kidney injury or chronic renal insufficiency
- •Contraindication/refusal to spinal anesthesia
- •Chronic pain
- •Chronic narcotic use
- •Illicit drug use
- •Allergy to any study related medications.
研究组 & 干预措施
Acetaminophen Oral
(group 2) 1 gram oral acetaminophen every 8 hours for three doses
干预措施: Acetaminophen Oral (Drug)
Acetaminophen Intravenous
(group 1) 1 gram IV acetaminophen every 8 hours for three doses
干预措施: Acetaminophen Intravenous (Drug)
结局指标
主要结局
Cumulative Postoperative Opiate Consumption
时间窗: 24 hours
Cumulative opiate consumption (IV morphine equivalents)
次要结局
- Time to First Opiate Rescue(48 hours)
- VAS (Visual Analog Scale)(24 hours)
- Time Discharge(24 hours postoperative)