The Effectiveness of Dexmedetomidine as an Adjuvant for Bupivacaine Caudal Block in Pediatric Open Appendectomy Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to First Rescue Analgesia:
研究概览
简要总结
This study aims to evaluate if adding dexmedetomidine to bupivacaine in a caudal block can provide longer and better quality pain relief for children after open appendectomy surgery. The study will also assess the effect of this combination on the quality of recovery, including the incidence of emergence delirium, and its overall safety profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA (American Society of Anesthesiologists) physical status I or II.
- •Legal guardian provides written informed consent.
排除标准
- •Refusal of participation by the legal guardian.
- •Known allergy or hypersensitivity to local anesthetics or dexmedetomidine.
- •Coagulation disorder or receiving anticoagulant therapy.
- •Active infection at or near the injection site.
- •Significant anatomical abnormalities of the lumbosacral spine.
- •Pre-existing neurological disorders, psychiatric disorders, or a history of convulsions.
- •Anticipated surgery time of more than 2.5 hours.
- •Patients with severe asthma or active wheezing.
研究组 & 干预措施
Control Group
Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 mL of normal saline.
干预措施: caudal block with bupivacaine (Procedure)
Experimental Group
Patients will receive a single-shot caudal block with 1 mL/kg of 0.25% bupivacaine mixed with 1 µg/kg of dexmedetomidine (diluted in 1 mL of normal saline).
干预措施: caudal block using dexmedetomidine with bupivacaine (Procedure)
结局指标
主要结局
Time to First Rescue Analgesia:
时间窗: Up to 24 hours post-caudal block
Defined as the time interval in minutes from the performance of the caudal block until the first administration of rescue analgesia (ibuprofen), which is prompted by a FLACC pain score of ≥ 4.
次要结局
未报告次要终点
研究者
Mohamed Tarek Hussein
doctor
Ain Shams University