Pethidine Versus Nitrous Oxide for Pain Relief During Labor Among Multiparous. A Randomized Controlled Trial
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
- Pain intensity
研究概览
简要总结
Systematic opioids and inhaled nitrous oxide (N2O ) are common methods for pain relief during labor. The aim of the current study is to evaluate the efficacy of systemic pethidine compared to N2O given for pain relieve in term, multiparous women in labor.
详细描述
Pain relief during labor and delivery is an essential part of good obstetrical care. Labor pain and its relief have implications on the course of labor, maternal and fetal outcomes and the satisfaction with childbirth overall. Many women would like to have a choice in pain relief during labor but also would like to avoid invasive methods of pain management in labor (as epidural). Both, inhaled analgesia and parenteral opioids are common pharmacological interventions aim to relieve the pain of labor.Nitrous oxide in a 50/50 mix with oxygen is the most common concentration used for labor pain management. It is self-administered via facemask, intermittently, and has rapid onset and offset effect. Main side effects, including nausea, vomiting, dizziness and drowsiness. Pethidine is one of the most frequently used opiate agonists. It can be given intravenous or intramuscularly. Its analgesic effect starts within 10-20 minutes and lasts 2-4 hours. Reported maternal side effects include nausea, vomiting and dysphoria. Pethidine may lead to changes in fetal heart rate tracing during labor, respiratory depression, impaired sucking reflex and restlessness.
Given the fact that these two routine interventions are given in different ways and have different side effects profile, the investigators aim in this randomized controlled trial to compare the analgesic effect of these two methods and their maternal and perinatal secondary effects in multiparous laboring women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Multiparity (para 2 or more).
- •Term pregnancy: 37-42 weeks of gestation.
- •Singleton pregnancy.
- •Vertex presentation.
- •In labor: at least 2 contraction in ten minutes and cervical dilatation of 2 centimeters or more.
排除标准
- •Women who desire epidural as a first line analgesia during labor.
- •Women receiving pethidine during the last 24 hours (prior to entering labor room).
- •Contra-indication for vaginal delivery.
- •Contra-indication or allergic reaction to either pethidine or nitrous oxide.
- •History of drug abuse.
- •Previous cesarean delivery.
研究组 & 干预措施
IV Meperidine
Intravenous injection of meperidine 50mg given in 100cc NaCl 0.9% over 10 minutes. Repeated doses (if needed) will be given in intervals of 2 hours minimum until a maximum of 4 doses.
干预措施: IV Meperidine (Drug)
Inhaled Nitrous Oxide
Nitrous oxide in a 50/50 mix with oxygen given via self-administered face mask. The parturient will be advised to place the mask tightly on her face and to breathe through it at the first sign of forthcoming uterine contraction. Between contractions, the parturient will be advised not to breath through the mask.
干预措施: Nitrous Oxide (Drug)
结局指标
主要结局
Pain intensity
时间窗: 20-30 minutes after drug administration.
Visual analogue scale
次要结局
- Breast feeding(Up to 48 hours after birth)
- Participants satisfaction and the usefulness of pain relief(Within 48 hours after birth)
- Pain intensity(60, 120 and 180 minutes from drug administration.)
- Time from drug administration to labor.(24 hours)
- Need for additional analgesia(24 hours)
- Side effects.(During 60 minutes from drug administration.)
- Changes in electronic fetal heart rate monitoring(24 hours)
- Occurence of meconium stained amniotic fluid(24 hours)
- Umbilical artery PH(Up to 5 min from birth, after performing cord clamping.)
- Apgar score(At 1 and 5 minutes after birth)
- Need for respiration(Within 48 hours after birth)
- Neonatal Intensive Care Unit (NICU) administration(Within 48 hours after birth)
研究者
Sivan Easton
Medical Doctor
HaEmek Medical Center, Israel