Premedication by Clonidine Intranasal in Pediatric Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Anxiolysis score
研究概览
简要总结
There are few studies using intra nasal way to dispense premedication in pediatrics.
This study will evaluate anxiolysis effect of Intranasal premedication with Clonidine vs Placebo.
Two groups, randomized,
Total of 150 patients (75 in each group) :
Involvement in study for one patient : 7 days Duration of study including inclusion and data analysis : 18 months (inclusion 12 months; data analysis 6 months)
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child from 1 to 5 years
- •Weight between 10 to 25 kgs
- •Scheduled minor surgery
- •Oral and written information and consent given by main investigator to both of the parents or legal(s) representative(s).
- •ASA score 1 or 2
- •Patient with social care insurance
排除标准
- •Refusal of one of the parental authority or legal representing
- •Concomitant participation to a clinical trial with use of a drug
- •Known hypersensitivity or contraindication to Clonidine or one of its excipients
- •Airway infection within 3 weeks before inclusion
- •Intravenous induction of anesthesia
- •Antecedent of arrhythmia or congenital heart disease
- •Mental disorder or current psychoactive medication
研究组 & 干预措施
Clonidine
This arm will receive intra nasal Clonidine as a premedication before surgery
干预措施: Clonidine (Drug)
Placebo
This arm will receive intra nasal Placebo as a premedication before surgery
干预措施: Placebo (Other)
结局指标
主要结局
Anxiolysis score
时间窗: at 30 minutes after premedication
Anxiolysis score (1 : Anxious, crying; 2 : Anxious; 3 : Calm, not cooperative; 4 : Calm, cooperative
次要结局
- Agitation score after the extubation(15 min after extubation)
- Acceptation of mask at the induction of anesthesia(1 hour after premedication)