Analgesic Efficacy of Transversus Abdominis Plane Block Versus Caudal Dexmedetomidine in Children Undergoing Abdominal Surgeries
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1st analgesic requirement
研究概览
简要总结
Acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. Children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each):
Group D: Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
Group T: TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 3-9 years old
- •Physical status I and II class of the American Society of Anesthesiologists (ASA)
- •Unilateral elective surgeries below the umbilicus
排除标准
- •Parents or legal guardian refusal.
- •History of developmental delay or mental retardation
- •Contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block.
- •Hemodynamic unstable patient.
研究组 & 干预措施
Caudal block with bupivacaine and dexmedetomidine
Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
干预措施: caudal block (Procedure)
Caudal block with bupivacaine and dexmedetomidine
Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
干预措施: Dexmedetomidine (Drug)
Caudal block with bupivacaine and dexmedetomidine
Caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg.
干预措施: Bupivacain (Drug)
TAP block with bupivacaine
TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
干预措施: TAP (Procedure)
TAP block with bupivacaine
TAP block with bupivacaine 0.25% in a dose of (0.5 ml / kg).
干预措施: Bupivacain (Drug)
结局指标
主要结局
1st analgesic requirement
时间窗: 12 hours
Time for first analgesic request (paracetamol intravenously 15 mg/kg) (h)
次要结局
- post operative pain score(12 hours)
- diastolic Blood Pressure (BP)(12 hours)
- Total paracetamol consumption(12 hours)
- Heart rate (HR)(12 hours)
- systolic Blood Pressure (BP)(12 hours)
- SpO2 -Hemodynamic assessment(12 hours)
研究者
Fouad Soliman
Lecturer of Anesthesia and ICU
Sohag University