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临床试验/NCT05919173
NCT05919173已完成4 期

UROLOGICAL SURGERIES IN CHILDREN: Comparison Between 0.25% Bupivacaine and 0.25% Bupivacaine withDexmedetomidine in the Caudal Block

Sindh Institute of Urology and Transplantation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月10日最近更新:
适应症
干预措施
相关药物

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

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%

Experimental

Bupivacaine 0.25% Dose: 1mL/kg body weight

干预措施: Bupivacaine Hydrochloride 0.25% Injection Solution (Drug)

Bupivacaine+DEX

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Shakil Malik

Assistant professor

Sindh Institute of Urology and Transplantation

研究点 (1)

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