CTRI/2023/07/055105尚未招募4 期
A comparative study of intravenous ketamine plus caudal bupivacaine to caudal bupivacaine plus ketamine for postoperative analgesia in children undergoing inguinal hernia surgeries
Indira Gandhi medical college and hospital1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年7月19日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare duration of prospective pain free period in paediatric patients following administration of subanaesthetic doses of intravenous ketamibe plus caudal bupivacaine to caudal bupivacaine plus ketamine
研究概览
简要总结
Caudal block is commonly performed for postoperative pain management in children undergoing abdominal and lower limb surgeries. Although it has its own contraindications and benefits. Ketamine in subanaesthetic doses possesses centrally mediated analgesic properties with minimal effects on consciousness and cognition of the patient.
However whether IV Subanaesthetic ketamine or caudal ketamine provides a level of postoperative analgesia that is similar to caudal bupivacaine in children is unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •The study will be carried out in 70 patients in age group of 2years- 6years.
排除标准
- •1.Refusal for consent by parents/ guardian.
- •2.Children with cardiovascular diseases.
- •Any history of bleeding or clotting disorder.
- •Local infection at the site of needle insertion.
- •History of allergy to local anaesthetics of ketamine.
- •Children with coagulopathy, pilonidal sinus or local site infections.
结局指标
主要结局
To compare duration of prospective pain free period in paediatric patients following administration of subanaesthetic doses of intravenous ketamibe plus caudal bupivacaine to caudal bupivacaine plus ketamine
时间窗: 24hrs
次要结局
- Secondary outcome in form of postoperative agitation, sedation etc.(24hrs)
- To measure the duration of pain free period & amount of analgesic consumption in first 24hrs postoperatively(24hrs)
- To evaluate requirement of rescue analgesia postoperatively(24hrs)
研究者
研究点 (1)
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