Efficacy of a sub-anesthetic dose of iv ketamine vs caudal epidural with bupivacaine for analgesia in children undergoing inguinoscrotal and lower extremity surgery under general anesthesia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To identify, the efficacy of sub-anesthetic dose of ketamine (0.30 mg/kg) compared to caudal bupivacaine (0.125%, 1ml/kg) for post op analgesia in pediatric patient. The response to pain is defined as FLACC score less than or equal to four immediately after surgery.
研究概览
简要总结
caudal epidural block has been commonly used in pediatric postoperative pain management in children undergoing lower abdominal surgeries. However, apart from procedural failure, there is the possible risk of accidental dural puncture, infection etc. Moreover, in children with coagulopathy and infection, it is contraindicated.
Ketamin, an NMDA - receptor antagonist is commonly used in pediatrics, at subanaesthetic IV doses(less than equal to 0.3mg/kg) possesses a centrally mediated analgesic properties, without increasing the risk of side effects seen with normal doses. Numerous clinical studies support the role of subanaesthetic doses of ketamine in acute pain settings. there are also very few studies comparing the efficacy of subanesthetic doses of ketamine vs caudal epidural in pediatrics.
Hence, this study was undertaken to determine the efficacy of subanaesthetic doses of IV ketamine (0.3mg/kg) vs caudal epidural with 1ml /kg of 0.125%bupivacain in children undergoing inguinoscrotal surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •children below 6yr and above 2 month posted for elective inguinoscrotal or lower limb surgery.
排除标准
- •children with contraindication to caudal anesthesia, or those with cardiovascular diseases, anaemia, known drug allergy to ketamine or bupivacaine, children with clotting disorders, or those whose parents/guardians refuse to provide consent.
结局指标
主要结局
To identify, the efficacy of sub-anesthetic dose of ketamine (0.30 mg/kg) compared to caudal bupivacaine (0.125%, 1ml/kg) for post op analgesia in pediatric patient. The response to pain is defined as FLACC score less than or equal to four immediately after surgery.
时间窗: post operative
The primary outcome of this study is to measure the proportion of patients achieving the response in each group.
时间窗: post operative
次要结局
- Difference in inflammatory markers (IL6 and TNF α) between two groups.