Comparison Between 2 Pain Analgesic Protocols Following Vaginal Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS) score difference in the 24 first hours.
研究概览
简要总结
Untreated postpartum pain has been associated with increased risk of opioid use, postpartum depression and development of persistent pain. In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
详细描述
More than two million women deliver vaginally every year in the United States (US). Along with the joy and happiness of having a new member in the family, women may suffer from cramping pain and lower abdomen discomfort following uterine involution; perineal pain due to perineal trauma or episiotomy; and nipple pain from breastfeeding or breast engorgement.
A stepwise approach using multimodal combination of medications can effectively provide an individualized pain management for women in their postpartum period. The first step includes non-opioid analgesics (as paracetamol and NSAIDs), step two adds milder opioids (as codeine, tramadol and oral morphine), and step three incorporates stronger opioids (as parenteral morphine).
In this study the investigators will investigate whether a scheduled administration of analgesics is superior to administration of analgesics based on patient request following a vaginal delivery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women following term vaginal delivery.
排除标准
- •Under Age 18 years or older than 45 years.
- •Women with chronic pain syndrome.
- •Women with relative or absolute contraindications for paracetamol or NSAIDs.
研究组 & 干预措施
Fixed time interval group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
干预措施: Paracetamol 1000 Mg Oral Tablet (Drug)
Fixed time interval group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
干预措施: Ibuprofen 400Mg Tab (Drug)
Fixed time interval group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen every 6 hours, in the first 24 hours postpartum. After 24 hours postpartum and until discharge, they will receive analgesics at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
干预措施: MIR (Drug)
'On-demand' group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
干预措施: Paracetamol 1000 Mg Oral Tablet (Drug)
'On-demand' group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
干预措施: Ibuprofen 400 mg (Drug)
'On-demand' group.
Patients received oral 1-gram paracetamol and 400 milligram ibuprofen at maternal request. At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet).
干预措施: MIR (Drug)
结局指标
主要结局
Visual analog scale (VAS) score difference in the 24 first hours.
时间窗: In the first 24 hours postpartum.
Pain control using visual analog scale (VAS) score of 0 (no pain/ least satisfaction) to 10 (worst pain/ highest satisfaction).
次要结局
- Amount of additional analgesia requirements.(Up to maternal discharge (5 days))
- Total analgesia requirements.(Up to 48 hours postpartum.)
- Breastfeeding rate.(Up to 48 hours postpartum.)
- Treatments side effects.(Up to 48 hours postpartum.)
- Visual analog scale (VAS) score difference up to maternal discharge.(At any time, if a woman experienced pain despite the prescribed treatment, the next line of treatment was MIR (morphine immediate release, 10 mg tablet). up to 5 days.)
研究者
Gal Bachar MD
Principal investigator
Rambam Health Care Campus