Combined Intravenous Tramadol and Paracetamol Versus Intramuscular Pethidine for Pain Relief During the First Stage of Labor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- The effect on pain relief
研究概览
简要总结
The goal of this intervention study is to compare the efficacy and adverse effects of pain relief during the first stage of labor using 75 mg IM pethidine versus the combination of IV 100 mg tramadol and 1000 mg paracetamol.
The investigator assume that the combination of IV tramadol and paracetamol will be more effective with less adverse effects than IM pethidine in pain relief at the first stage of labor.
The investigator primary outcome is The effect on pain relief according to numeric rating scale (NTS) in the study groups Before the administration of the drugs, fetal heart rate patterns and contractions will be recorded with cardiotocography monitor for at least 20 min. The investigator will evaluate vigilance at 30 minutes following drug administration.
NRS pain score (0-10) will be collected before administration and one hour after drug administration
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton Term pregnancy First stage of labor including at least 4 painful contractions in 30 min with cervical dilatation less or equal to 1 cm or 50% effacement Spontaneous or induced labor -
排除标准
- •Previous cesarean delivery
- •Malpresentation
- •Multiple pregnancies
- •Suspected intrauterine growth restriction < 3 percentile
- •Suspected placental abruption
- •History of allergy to paracetamol, tramadol or pethidine
- •Women with sleep apnea disorder
- •Morbid obesity BMI≥40
- •History of significant cardiac, liver and renal diseases
- •Anti-convulsive medication consumption
- •MAO inhibitors medication consumption within the last 14 days
- •Non reassuring fetal heart rate monitoring (type II or III)
- •Tense use
研究组 & 干预措施
Combination of paracetamol and tramadol
Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min
干预措施: Tramadol (Drug)
Combination of paracetamol and tramadol
Women will receive intravenous infusion of 50 ml contain 1000mg paracetamol and 100ml contain 100mg tramadol over 15 min
干预措施: Paracetamol 1 g (Drug)
Pethidine
75 mg of pethidine will be given intramuscularly in the upper - outer quadrant of the
干预措施: pethidine (Drug)
结局指标
主要结局
The effect on pain relief
时间窗: one hour after drug administration.
according to numeric rating scale (NRS), which runs from 0-10, where 0 is "no pain" and 10 is the "worst pain.
次要结局
- Maternal adverse effects of the medications(from enrollment to 72 hours after birth)
- First stage of labor duration (hours)(from enrollment to 72 hours after birth)
- Women satisfactory rate by NRS- a scale between 1-5, where 1 is no satisfactory and 5- is excellent satisfactory(from enrollment up to 72 hours after the birth)
- The need for additional analgesia (Epidural, pethidine IV, nitrous)(from enrollment to 72 hours after birth)
- Fetal and neonatal outcomes(from enrollment to 72 hours after birth)
- Pregnancy outcomes(from birth up to 72 hours after birth)
研究者
Zohar Nachum
Professor
HaEmek Medical Center, Israel