Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Comfort measured by a visual analogue scale for pain
研究概览
简要总结
Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.
详细描述
Assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.
Compare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter for insulin administration vs. a metal needle.
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
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 5 to 18 years, admitted with diagnoses of DKA. DKA is defined when patients meets all the following biochemical baseline criteria (before initial hydration):
- •Glucose> 200 mg / dl
- •pH < 7.3
- •Bicarbonate < 15mmol/l.
排除标准
- •Patients referred from another institution with a different treatment, and those who requires intensive care on admission.
研究组 & 干预措施
flexible catheter
The flexible Subcutaneous catheter for insulin administration
干预措施: FLEXIBLE CATHETER (Device)
hourly rigid needle puncture
Hourly rigid needle puncture for Subcutaneous insulin administration
干预措施: hourly rigid needle puncture (Device)
结局指标
主要结局
Comfort measured by a visual analogue scale for pain
时间窗: between 10 to 14 hours
Comfort measured by a visual analogue scale for pain (10cm = 0 meaning no pain and 10 meaning maximum pain) shown hourly after insulin administration until metabolic stability is achieved.
次要结局
- Associated complications(24 hours)
- Metabolic stability according to lab determinations(between 10 to 14 hours)