Local Subfascial and Intramuscular Tranexamic Acid Administration in Pediatric Patient Undergoing Scoliosis Surgery, Double Blind Randomized Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Intraperative blood loss in both groups
研究概览
简要总结
We hypothesized that local administration of tranexamic acid will minimize blood loss and blood product administration in pediatric patient undergoing scoliosis surgery
详细描述
Spine surgery in paediatrics is frequently associated with substantial blood loss.
Blood product adminestration in children has many complications that are not fully known.
There are many modalities currently available to reduce blood loss in pediatric patients.
Tranexamic acid is tissue plasminogen activator inhibitor that reduce perioperative blood loss.
To date, no studies have investigated effect of local administration of tranexamic acid in pediatric population undergoing scoliosis surgery.
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
- Single (Care Provider)
盲法说明
surgeon will be blinded to type of injection
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2-12 years
- •Of both sexes
- •American society of anesthesiologist (ASA) physical status classification class I
- •Undergoing general anesthesia for scoliosis surgery
排除标准
- •Parents' refusal of regional block
- •Known allergy to tranexamic acid
- •Bleeding disorders (INR >1.4,Platelet count< 75000)
研究组 & 干预措施
Group T (tranexamic acid),n=15
Group T: tranexamic acid 10 mg/kg will be injected locally
干预措施: Tranexamic acid injection (Drug)
Group S (saline) (n=15)
Group S saline will be injected
干预措施: Saline (Drug)
结局指标
主要结局
Intraperative blood loss in both groups
时间窗: period of surgery(1-2 hours)
amount of blood/kg(ml/kg)
次要结局
- post-operative blood loss(24 hours)
- Blood product admenestration(duration of procedure(1-2 hours))