Premedication With Intranasal Dexmedetomidine or Midazolam for Prevention of Emergence Agitation in Children: Superiority Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Emergence agitation
研究概览
简要总结
Study where children will receive one premedication, either intranasal dexmedetomidine or oral midazolam, to reduce agitation on emergence of anesthesia. The hypothesis is that dexmedetomidine is superior but previous studies lack quality.
详细描述
Children will be randomized to receive, either midazolam (0.5mg/kg) or dexmedetomidine (1mcg/kg), as anesthetic premedication. Emergence agitation will be assessed by PAED scale.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants will not know which group they will be allocated. The anesthesia care provider will not know which premedication the patient received because another professional, who is not from the research team, will provide it to the child. The investigator and outcome assessor will only know the allocated group latter by a code which will be revealed after the end of the analysis.
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for amygdalectomy
- •American Society of Anesthesiologists Physical Status PI or PII
- •Absence of congenital neuropathy
- •Absence of cardiac pathology (any)
- •Intolerance to one of the studied drugs.
排除标准
- •Protocol violation
- •Need to transfer for ICU intubated
研究组 & 干预措施
Dexmedetomidine
Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Children will receive 1mcg/kg intranasal dexmedetomidine and oral saline, 30 minutes before going to operation theater.
干预措施: Oral saline (Drug)
Midazolam oral solution
Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater.
干预措施: Midazolam oral solution (Drug)
Midazolam oral solution
Children will receive 0,5mg/kg oral midazolam and intranasal saline, 30 minutes before going to operation theater.
干预措施: Nasal saline (Drug)
结局指标
主要结局
Emergence agitation
时间窗: 15 minutes
Anesthesiologist provider's reported score on PAED (Paediatric Anesthesia Emergence Scale) during the first 15 minutes after the extubation. The PAED consists of four items. Each item is scored 0-4 yielding a total between 0 and 20.
次要结局
- Bradycardia(2 hours)
- Hypotension(2 hours)
- Intraocular pressure(15-minutes)
- Respiratory depression(30 minutes)
- Paradoxal agitation(30 minutes)
研究者
Gabriel Magalhaes Nunes Guimaraes
Head of anesthesiology
Brasilia University Hospital