The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- The incidence of dexamethasone-induced perineal irritation
研究概览
简要总结
The purpose of this study is to investigate the efficacy of dilution with glucose and prolonged injection time on dexamethasone 21-phosphate induced perineal irritation (include pian and pruritus).
详细描述
Dexamethasone is a synthetic glucocorticoid, which may cause perineal irritation when given intravenously. The major clinical manifestations are pruritus and pain，and the incidence vary between 38%-71%. Some patients undergo spontaneous remission, while others develop into severe pain or pruritus. In clinical practice, dexamethasone is always diluted with glucose in many cases, but diluted dexamethasone in relieving dexamethasone induced perineal irritation has not been studied yet. The aim of this study was to investigate the efficacy of dilution with glucose on dexamethasone induced perineal irritation.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •ASA physical status I-II
排除标准
- •On regular use of analgesic
- •Contraindication or allergy to steroid or glucose
- •Drug or alcohol abuse
- •Diagnosed with paresthesia or mental diseases
- •Communication disorders
- •Pregnancy or nursing
研究组 & 干预措施
2 ml dexamethasone (5 mg/ml)
50 patients receive 2 ml dexamethasone (5 mg/ml) , the injection time of dexamethasone was less than 2s.
干预措施: Dexamethasone (Drug)
5 ml dexamethasone (2mg/ml)
50 patients receive 5 ml dexamethasone (2mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
干预措施: Diluted dexamethasone 5ml (Other)
10 ml dexamethasone (1mg/ml)
50 patients receive 10 ml dexamethasone (1mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
干预措施: Diluted dexamethasone 10ml (Other)
20 ml dexamethasone (0.5mg/ml)
50 patients receive 20 ml dexamethasone (0.5mg/ml) diluted with 5% glucose, the injection time of dexamethasone was 30s.
干预措施: Diluted dexamethasone 20ml (Other)
结局指标
主要结局
The incidence of dexamethasone-induced perineal irritation
时间窗: During the first 3 min period after the injection of dexamethasone
The investigators record the number of cases of dexamethasone-induced perineal irritation (pain or pruritus) and calculate the incidence
次要结局
- Duration of perineal irritation(After the injection of dexamethasone, up to 5 minutes)
- The severity of perineal irritation(After the injection of dexamethasone, up to 5 minutes)