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临床试验/NCT04331418
NCT04331418已完成不适用

Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery

Tanta University1 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2020年3月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
135
试验地点
1
主要终点
quality of recovery of the studied patients

研究概览

简要总结

Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence.

Various multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge.

In our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia.

Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers.

It also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • male children
  • american society of aneasthesia physical status grade I &II
  • patients aged from 2 years to 12 years
  • patients will undergoing hypospadias repair surgery

排除标准

  • history or evidence of infection at the back
  • allergy to the study drugs
  • bleeding/coagulation disorder
  • developmental delay
  • septic patients
  • neurological or spinal diseases.

研究组 & 干预措施

caudal group

Experimental

After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.

干预措施: caudal block (Procedure)

dexmetomidine group

Experimental

Children in this group will be received (1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr) with a suggested maximum dose of 2 mcg/kg.of dexmedetomidine is available in a 100 mcg/mL concentration in a 2 mL preservative-free vial. It may be prepared as a 2 to 4 mcg/mL solution using normal saline

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

quality of recovery of the studied patients

时间窗: from discharge from PACU up to 6 hours in the surgical ward

change in quality of recovery of the studied patients using modified objective pain score

次要结局

  • concentration of required postoperative analgesic(from discharge from PACU up to 6 hours in the surgical ward)
  • concentration of required postoperative sedation(from discharge from PACU up to 6 hours in the surgical ward)
  • number of patients developed perioperative complications.(from discharge from PACU up to 6 hours in the surgical ward)

研究者

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

Amany Faheem

Principal Investigator

Tanta University

研究点 (1)

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