A Comparison of Venous Tolerability and Injection Pain of a Modified Propofol Preparation and Standard Propofol in the Induction of Anesthesia in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- incidence of spontaneous expression of pain during injection
研究概览
简要总结
The purpose of the study is to determine wether a modified propofol preparation shows any effect on the incidence of injection pain in children undergoing elective surgery under general anesthesia.
Study hypothesis: The use of a modified propofol preparation will reduce the incidence of injection pain in the study group.
详细描述
Pain on injection is the most frequently reported side effect associated with the use of propofol for induction of anesthesia. Various measures have been taken to reduce the pain on injection, e.g. administration of lidocaine or fentanyl prior to propofol administration, mixture of lidocaine and propofol as well as cooling of the emulsion. Although pain on injection had been reduced with some of the above mentioned methods, they may not be regarded as a satisfactory solution of the problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 2 and < 6 years
- •written informed consent of the parents
- •anesthetic risc classified as ASA I - III
- •patient undergoing elective surgery under general anesthesia
- •venous access for induction of anesthesia on the dorsum of the hand
- •hospital care for at least 3 hrs after end of anesthesia guaranteed
排除标准
- •intolerability of the drugs tested
- •current drug medication with sedative effect
- •patient is expected to require concomitant medication not allowed in the study
- •history of or current renal or hepatic disease, cardiac insufficiency
- •hypovolemia
- •increased cranial pressure
- •simultaneous participation in another clinical trial or participation during the month preceding this study
结局指标
主要结局
incidence of spontaneous expression of pain during injection
次要结局
- anesthetists VAS for assessment of injection pain, propofol dosage and requirements, hemodynamic parameters, safety laboratory, adverse events