UROLOGICAL SURGERIES IN CHILDREN: Comparison Between 0.25% Bupivacaine and 0.25% Bupivacaine withDexmedetomidine in the Caudal Block
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Post operative Pain
研究概览
简要总结
The aim of this study is to compare the duration of analgesia, sedation, and intra and postoperative hemodynamics. This drug is recently available in Pakistan. To the best of our knowledge, no published data is available in this respect in Pakistan, so this study would in turn help to fill the gap in knowledge in low-resource settings/emerging economy.
详细描述
Postoperative pain is an annoying subjective sensation for both children and their parents. Almost 80% of the patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity. Management of postoperative pain has become a major concern in pediatrics. Results of many studies in different countries show that postoperative pain in children is inadequate. Lee et al showed that one of the main reasons for inadequate treatment of postoperative pain in children is difficulties with pain assessment and concerns related to the side effects of opioid analgesics.
The regional anesthetic technique significantly decreases postoperative pain and systemic analgesic requirements. Caudal block, usually combined with general anesthetic technique is one of the most popular, reliable, and safe anesthesia techniques for abdominal and lower limb surgeries in children but the main disadvantage of caudal analgesia is the short duration of action after a single injection.
Bupivacaine is a long-acting, reliable local anesthetic agent that is used as a caudal analgesic, but different auxiliary agents need to be co-administered to improve its analgesic efficiency. Various additives used in the past to increase the pain-free period postoperatively and to decrease the analgesic requirement such as midazolam neostigmine, ketamine, clonidine, and dexmedetomidine.
Dexmedetomidine is a potent and highly selective alpha 2 adrenergic agonists that has been described as safe and effective in many anesthetic applications and analgesic techniques. In contrast to other agents, it has sympatholytic, analgesic, and sedative effects, and is randomly free from side effects except for manageable hypotension and bradycardia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Months 至 7 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA 1 & 2
- •elective per-urethral cystolithotripsy
排除标准
- •History of developmental delay or mental retardation
- •Known or suspected coagulopathy
- •Known allergy to any of the study drugs
- •Any signs of infection at the site of the proposed caudal block
- •Any caudal anatomical deformity
研究组 & 干预措施
Bupivacaine 0.25%
Bupivacaine 0.25% Dose: 1mL/kg body weight
干预措施: Bupivacaine Hydrochloride 0.25% Injection Solution (Drug)
Bupivacaine+DEX
Bupivacaine 0.25% plus Dexmedetomidine 1microgram/kg Dose: 1mL/kg
干预措施: Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight (Drug)
结局指标
主要结局
Post operative Pain
时间窗: 24 hour post operatively
* face, legs, activity, cry, and consolability (FLACC) behavioral pain scale * Each category is scored on the 0-2 scale which results in a total score of 0-10. * Assessment of FLACC Pain Score: * 0 = Relaxed and comfortable * 1-3 = Mild discomfort * 4-6 = Moderate pain * 7-10 = Severe discomfort/pain
次要结局
未报告次要终点
研究者
Dr. Shakil Malik
Assistant professor
Sindh Institute of Urology and Transplantation
