To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- The efficacy of pain management
研究概览
简要总结
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).
The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).
The protocols will be used for the first 48 hours following surgery.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women that underwent cesarean section
排除标准
- •Women suffering from chronic pain
- •Women using chronic pain medications
- •Allergy to any drug used in the study
- •Women underwent general anesthesia during the surgery
- •women with elevated liver enzymes
研究组 & 干预措施
Fix protocol
During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication):
At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams
After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams).
After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams.
Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day.
The total amount of paracetamol is limited to 4 gr per day.
干预措施: Fix protocol (Drug)
medications following demand protocol
The same combinations will be given as in the fixed protocol however only after patient request
干预措施: medications following demand protocol (Drug)
结局指标
主要结局
The efficacy of pain management
时间窗: during 48 hours from surgery
Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain
次要结局
- to compare the amount of breastfeeding between 2 groups(following the week after surgery)
- The number of times that pain medications were given in each study group(during 48 hours following surgery)
- Patient satisfaction(48 hours after surgery)
- adverse effect of the medications given in each protocol(during 48 hours following surgery)
- The necessity of additional medications (rescue doses)(During 48 hours after surgery)