Comparative Evaluation of Caudal Dexmedetomidine and Caudal Ketamine as Adjuvants to Isobaric Bupivacaine for Postoperative Analgesia in Children Undergoing Surgery for Developmental Dysplasia of the Hip
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score (FLACC)
研究概览
简要总结
This study compares two medicines, Dexmedetomidine and Ketamine, added to caudal Bupivacaine to control pain after hip surgery in children. We will check how well each medicine reduces pain, how long the pain relief lasts, and if children need extra pain medicine. The goal is to find the safest and most effective option for postoperative pain relief in children undergoing hip surgery.
详细描述
Background:
Postoperative pain control is a major concern in pediatric patients undergoing surgery for developmental dysplasia of the hip (DDH). Caudal epidural block with Isobaric Bupivacaine is a common technique, but its duration of analgesia is limited. Adjuvants such as Dexmedetomidine and Ketamine may prolong analgesia and improve postoperative comfort.
Objective:
To compare the efficacy and safety of caudal Dexmedetomidine versus caudal Ketamine as adjuvants to Isobaric Bupivacaine for postoperative analgesia in children undergoing DDH surgery.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Double-blind study: neither the patient, the anesthesiologist administering the block, nor the assessor recording pain scores will be aware of group allocation.
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 6 years undergoing surgery for developmental dysplasia of the hip
- •ASA physical status I or II
- •Parental or guardian informed consent obtained
排除标准
- •Known allergy to local anesthetics, Dexmedetomidine, or Ketamine
- •Coagulopathy or bleeding disorders
- •Infection at the site of caudal injection
- •Neurological disorders
- •Severe systemic disease
- •Refusal of parental consent
研究组 & 干预措施
Dexmedetomidine Group
Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Dexmedetomidine 1 µg/kg for postoperative analgesia.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine Group
Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Dexmedetomidine 1 µg/kg for postoperative analgesia.
干预措施: Bupivacaine (Drug)
Ketamine Group
Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Ketamine 0.5 mg/kg for postoperative analgesia.
干预措施: Ketamine (Drug)
Ketamine Group
Children receiving caudal Isobaric Bupivacaine 0.25% (1 ml/kg) with Ketamine 0.5 mg/kg for postoperative analgesia.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Postoperative Pain Score (FLACC)
时间窗: First 24 hours post-surgery
Pain will be assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at regular intervals (every 2-4 hours) during the first 24 hours after surgery to evaluate the effectiveness of caudal analgesia in children receiving Dexmedetomidine or Ketamine as adjuvants to Bupivacaine.
次要结局
- Hemodynamic Stability(Intraoperative and first 24 hours post-surgery)
- Duration of Analgesia(From caudal block to first request for rescue analgesia)
- Adverse Effects(First 24 hours post-surgery)
- Rescue Analgesia Requirement(First 24 hours post-surgery)
研究者
Esraa Abdelmonem Ahmed Mahmoud
Resident of Anesthesiology, Assiut University Hospital
Assiut University