Remifentanil Versus Paracetamol for Pain Treatment External Cephalic Versions.
Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked
BACKGROUND: Between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. The external version is a maneuver gynecological used to turn a breech in cephalic presentation. For treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination.
OBJECTIVE: To compare the effectiveness of remifentanil for pain management in external version.
PATIENTS: Pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. Participants will be randomized into two groups before the procedure.
Group intervention: paracetamol and remifentanil Control group: paracetamol and placebo DETERMINATIONS: VAS pain level, percentage of success of the maneuver and adverse events.
Statistical Analysis: Comparison of pain recorded by VAS in both groups and comparison of adverse events
研究概览
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Alava
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Vitoria-Gasteiz、Alava、西班牙、01009
- Hospital Txagorritxu
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation.
- Informed consent signed by the mother or legal representative in his absence.
Exclusion Criteria:
- Fetal anomalies
- Severe hypertension
- Allergy to drug used in the test
- Amniotic fluid index ≥ 5 cm
- Contraindication for vaginal delivery
- Uterine abnormality and impaired coagulation
- Placenta previa
- Rh sensitization
- Multiple gestation
- Ruptured membranes
- Premature detachment of normally inserted placenta
- The mother greater weight to 85kg
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Remifentanil
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intervention: intravenous paracetamol 1g and remifentanil 1mg/100ml in 100ml of 0.9% saline.
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有源比较器：Paracetamol
intravenous paracetamol 1g
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Control group: intravenous paracetamol 1g
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Degree of decrease in pain experienced by patients during the maneuver according to the VAS
大体时间：10 minutes
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10 minutes
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.
大体时间：1 day
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1 day
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Number of adverse events and severity
大体时间：1 day
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1 day
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合作者和调查者
调查人员
- 首席研究员：Cesar A Valero, MD、Basque Health Service
- 学习椅：Henar Muñoz, MD、Basque Health Service
- 学习椅：Amanda Lopez、Basque Health Service
- 学习椅：Sandra Guerra, MD、Basque Health Service
- 学习椅：Olga Echebarria, MD、Basque Health Service
- 学习椅：Alfonso Velasco, MD、University of Valladolid
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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