Comparative Evaluation of dexmedetomidine versus dexamethasone as an adjuvant to bupivacaine in bilateral suprazygomatic maxillary nerve block for postoperative analgesia in children undergoing cleft palate surgeries : A Randomized, Prospective, Double-Blind Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time for first rescue analgesia
研究概览
简要总结
This study is a randomized, prospective, double-blind clinical trial designed to compare the effectiveness of dexmedetomidine and dexamethasone as adjuvants to bupivacaine in bilateral suprazygomatic maxillary nerve blocks for providing postoperative analgesia in children undergoing cleft palate surgery. The aim is to evaluate which adjuvant offers superior pain relief, longer duration of analgesia, and better safety profile in the pediatric population, thereby contributing to improved postoperative outcomes and reduced need for systemic analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 8.00 Month(s) 至 5.00 Year(s)（—）
- 性别
- All
入选标准
- •Children posted for elective cleft palate repair under general anaesthesia Aged between 8 months to 5 years ASA category I and II Willing to give consent.
排除标准
- •Lack of Parental consent Allergic to local anesthetics Coagulation disorders Local infection or lesion at the proposed puncture site Language difficulties Cognitive disorders Comorbid conditions like congenital heart diseases airway obstruction disease and central nervous system disorders.
结局指标
主要结局
Time for first rescue analgesia
时间窗: Time for first rescue analgesia 24 hours | duration of analgesia 24 hours
Duration of analgesia
时间窗: Time for first rescue analgesia 24 hours | duration of analgesia 24 hours
次要结局
- Postoperative FLACC score(Total Postoperative fentanyl consumption)
研究者
Amanpreet Singh
AIIMS New Delhi