CTRI/2018/08/015288尚未招募1 期
A comparative study of analgesic efficacy of caudal Ropivacaine with clonidine or dexamethasone as adjuvants in paediatric infraumbilical surgeries – An open labelled Randomised control trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the efficacy of ropivacaine with clonidine or dexamethasone as adjuvants for caudal epidural block in paediatric infraumbilical surgeries.
研究概览
简要总结
Caudal block is common regional technique used to provide postoperative pain in paediatric patients, many adjuvants are used with local anaesthetics to increase duration of analgesia to minimise the side effect of toxicity of local anaesthetic. In our study we compare analgesic efficacy of caudal Dexamethasone or Clonidine as adjuvants with ropivacaine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Age between 1 to 10 years •weight of child less than 30kg •American Society of Anesthesiologists (ASA) grade I and II patients •Children posted for infraumbilical surgeries less than 2 hour duration (herniotomy, urethroplasty,circumcision, orchidopexy, lower limb orthopaedic surgeries etc).
排除标准
- •1.Children posted for emergency surgery 2.Infection at the site of injection 3.Coagulopathy or on anticoagulation therapy 4.Congenital anomaly of lower spine and meninges 5.Active disease of the CNS 6.History of allergy to local anaesthetics, Clonidine and Dexamethasone 7.Surgeries in prone position.
结局指标
主要结局
To compare the efficacy of ropivacaine with clonidine or dexamethasone as adjuvants for caudal epidural block in paediatric infraumbilical surgeries.
时间窗: To evaluate duration of analgesia (defined as time from caudal injection until the first requirement of rescue analgesia, pain assessed by FLACC).
次要结局
- 1.To assess haemodynamic stability between the two groups.(2.To assess incidence of any side effects like nausea and vomiting, sedation, bradycardia, hypotension, wound infection)
研究者
研究点 (1)
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