Patient-controlled Intravenous Analgesia With Remifentanil Infusion for Labour: is Demand Bolus Required for Optimal Analgesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Epidural analgesia for pain relief in labor may not be suitable for all patients, and intravenous patient controlled analgesia (IV PCA) with opioids offers the best alternative. The purpose of this study is to assess the effectiveness of two methods remifentanil administration in the form of either an infusion or PCA demand bolus (intravenous injection of a single dose over a short period of time). Currently, our hospital gives remifentanil by demand bolus, however it may be equally effective, with less side effects, to give the drug as an infusion.
详细描述
The study will be conducted as a randomized trial with two arms: Group I- continuous infusion of remifentanil with stepwise increase in infusion rates and Group II- demand bolus only with stepwise increase in bolus dose, as per the patient's analgesic requirement. Visual analog scores will be the primary outcome. Maternal and fetal side effects will be recorded. The results of this study will determine the regimen that suits the patients needs for painless labor with high efficacy, less adverse effects and a higher patient satisfaction.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written informed consent
- •Term pregnancy in labour with singleton fetus in cephalic presentation
- •Patients requesting systemic analgesia
- •Patients with contraindication for regional anesthesia without fetal compromise (coagulopathy, thrombocytopenia, refusal, etc.)
排除标准
- •Refusal to sign written informed consent
- •Inability to communicate in English
- •Opioid dependence or addiction
- •Patients on Methadone
- •Allergy or hypersensitivity to remifentanil
- •Fetal heart rate abnormalities
- •Fetal congenital anomalies
研究组 & 干预措施
Continuous infusion
Remifentanil administered by continuous IV infusion, with stepwise increase in infusion rates and placebo demand bolus of normal saline.
干预措施: Remifentanil (Drug)
Demand Bolus
Demand bolus of remifentanil with stepwise increase in bolus dose and placebo continuous infusion of normal saline.
干预措施: Remifentanil (Drug)
结局指标
主要结局
Pain score
时间窗: 24 hours
Verbal Numeric Rating Scale (VNRS) from 0 to 10 (where 0 = no pain and 10 = worst pain felt), approximately every hour, throughout labour.
次要结局
- Consumption of remifentanil(24 hours)
- Crossover to epidural(24 hours)
- Side effects(24 hours)
- Fetal & Neonatal outcomes(48 hours)
- Maternal satisfaction(24 hours)