Remifentanil Versus Placebo for Pain Treatment External Cephalic Versions. Randomized, Controlled and Masked
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Degree of decrease in pain experienced by patients during the maneuver according to the VAS
研究概览
简要总结
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Remifentanil
干预措施: remifentanil (Drug)
Paracetamol
intravenous paracetamol 1g
干预措施: paracetamol (Drug)
结局指标
主要结局
Degree of decrease in pain experienced by patients during the maneuver according to the VAS
时间窗: 10 minutes
次要结局
- Proportion of patients in each group in which the procedure is effective and avoids performing a Caesarean section.(1 day)
- Number of adverse events and severity(1 day)