jRCTs061200032招募中不适用
The feasibility analyses of intranasal dexmedetomidine for premedication in pediatric patients
未提供0 个研究点目标入组 60 人开始时间: 2021年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 主要终点
- Acceptance of oral midazolam
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 15age old not（—）
- 性别
- All
入选标准
- •Pediatric patients under 15 years who are scheduled to undergo dental treatments under general anesthesia at the Center of the Special Needs Dentistry of Okayama University Hospital.
- •Pediatric patients who need premedication for anesthesia induction becasue of their non-cooperation.
- •Patients who exhibit an American Society of Anesthesiologists (ASA) physical status of 1 or 2.
排除标准
- •Pediatric patients who have a medical history of anaphylaxis against midazolam and/or dexmedetomidine.
- •Pediatric patients who contraindicate for the use of midazolam (acute angle-closure glaucoma, myasthenia gravis, using HIV protease inhibitor, medicines including Efavirenz or Cobicistat and/or Nirmatrelvir/Ritonavir, shock, coma, and acute alcoholic intoxication with vital sign inhibitions )
- •Pediatric patients who the principal investigator or co-investigator decide to be inadequacy for participants.
结局指标
主要结局
Acceptance of oral midazolam
The numbers and rates of patients who accepted oral midazolam
Rejection of oral midazolam but acceptance of nasal dexmedetomidine
The numbers and rates of patients who rejected oral midazolam but accepted nasal dexmedetomidine
Rejection of both oral midazolam and nasal dexmedetomidine
The numbers and rates of patients who rejected both oral midazolam and nasal dexmedetomidine
次要结局
未报告次要终点
研究者
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