Non - Opioid Treatments (Single Administration) for Pain During the Early Postpartum Period After Vaginal Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Pain relief after treatment with Paracetamol or Ibuprofen
研究概览
简要总结
The investigators will examine the effectiveness of non-opioid analgesia (Paracetamol versus Ibuprofen) in the early postpartum period
详细描述
Postpartum pain is a common problem that leads to difficulties in basic daily activities, overuse of opioid medications, and even impaired breastfeeding ability. Non-opioid analgesia may play an essential role in reducing pain and improving the postpartum period including the ability to breastfeed and caring for the newborn.
This study will compare non-opioid treatment - 1000 mg Paracetamol versus 400 mg Ibuprofen in order to determine the optimal pain relief treatment in the early postpartum period that may decrease the use of opioid analgesia.
The investigators will evaluate the pain by the Numerical Rating Scale (NRS) index in the early postpartum period. The evaluation will conduct at 4-time points - while the women taking the pain relief (time 0), an hour later (time 1), 4, and 6 hours later (time 4 and time 6).
The investigators will compare the analgetic effect of each drug and evaluate the need for additional analgesia whether opioid or not.
Furthermore, the investigators will examine when women sought pain relief and whether pain relief contributes to the ability of Breastfeeding.
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
- Double (Participant, Care Provider)
盲法说明
The primary investigator will be the only one to have the information about envelopes contain
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18-50, who gave birth in a vaginal birth
排除标准
- •Sensitivity to Paracetamol or Ibuprofen
- •After cesarean section
- •Received analgesia prior to study recruitment
- •Perineal tears grade 3 \ 4
- •Women with chronic pain, rheumatic disease, fibromyalgia, or trauma
- •Women with a diagnosis or medication for anxiety or depression
- •Dropout for women whose newborns needed respiratory support with intubation, cooling, prolonged hospitalization in NICU exceeding one week
研究组 & 干预措施
Paracetamol group
Women who were treated with a double-blind mechanism in an envelope containing paracetamol pills (1000 mg)
干预措施: Paracetamol 1000 mg (Drug)
Ibuprofen group
Women who were treated with a double-blind mechanism in an envelope containing Ibuprofen pills (400 mg)
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
Pain relief after treatment with Paracetamol or Ibuprofen
时间窗: 6 hours after intervention
After getting a pain relief treatment, the participants will answer a questionnaire about pain relief at 4 - time points: the time of getting the pain relief treatment (time 0), after an hour (time 1), 4 hours (time 4), and six hours (time 6). The pain rating will be on the Numeric Rating Scale (NRS) that labeled from zero (no pain) to ten ((worst pain).
次要结局
- Maximum pain location(6 hours after intervention)
研究者
Shmuel Kivity, MD
director head of clinical trails department, principal investigator, clinical professor
Tel-Aviv Sourasky Medical Center