Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Success of Pneumatic Reduction
研究概览
简要总结
Intussusception is one of the most frequent causes of acute bowel and second most common cause of acute abdominal pain in pediatric age .95 % of cases are idiopathic, the rest are either due to pathological lead point or post operative. Treatment of intussusception must start with medical resuscitation, then radiological or operative reduction of intussusception.
Our surgery team has used hydrocortisone with the medical resuscitation to improve the success rate of pneumatic reduction and decrease the number of reduction trials.
详细描述
Experimental group will be given single dose IV Hydrocortisone 10 mg/kg with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.
Control group will be given Saline 100 ml IV single injection with Resuscitation before attempting first trial of pneumatic reduction and the outcome measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infantile Intussusception
排除标准
- •Peritonitis Pneumoperitoneum Morbid patients
研究组 & 干预措施
Hydrocortisone
Hydrocortisone IV 10 mg/kg with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
干预措施: Hydrocortisone (Drug)
Saline
Saline IV 100 ml with Resuscitation before attempting reduction, single dose with Resuscitation before attempting reduction
干预措施: Saline (Drug)
结局指标
主要结局
Success of Pneumatic Reduction
时间窗: 1 Hour
Comparing number of Successful Pneumatic Reductions in both groups
次要结局
- Reducing number of trials of Pneumatic Reduction(2 Hours)
- Reducing complications(2 Hours)
研究者
Mahmoud El Fiky
Lecturer of Pediatric Surgery
Cairo University