Intranasal Dexmedetomidine Versus Midazolam for Premedication in Deep-sedated Pediatric Dental Patients: a Double-blinded, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- venipuncture acceptance
研究概览
简要总结
It is important to choose an appropriate analgesia/sedation technique in pediatric dental treatment. Premedication combined with intravenous anesthesia is often used in deep sedation technique for pediatric dental treatment and it's a routine in most hospitals. Deep sedation has its unique advantages such as avoiding the airway damage with an enhanced recovery.
Dexmedetomidine is suitable for intranasal mucosal administration as a premedication drug. It has been proved with several beneficial characteristics in other clinical procedures.
This study intends to further explore the characteristics of nasal dexmedetomidine as premedication in pediatric oral treatment under deep sedation.
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)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children in need of deep sedation for dental treatment aged 3-7 years.
- •anticipated operation time 1-2hours
排除标准
- •any known medical records with neural or mental disorder
- •any known medical records with severe systemic disorder
- •history of sedation drug administration in recent 1 months
- •any known allergic history of dexmedetomidine, midazolam or propofol
- •morbid obesity
- •history of OSAHS or acute respiratory infection in 2 weeks
- •other conditions which the attending considers to be unfit for the trial
研究组 & 干预措施
dexmedetomidine
2ug/kg intranasal atomized dexmedetomidine
干预措施: Dexmedetomidine (Drug)
midazolam
0.2mg/kg intranasal atomized midazolam
干预措施: Midazolam (Drug)
结局指标
主要结局
venipuncture acceptance
时间窗: Day 0
acceptance while starting the IV line, at most 2 tries
次要结局
- hypoxemia(Day 0)
- post-operative agitation(Day 0)
- discharge time(Day 0)
- times of intra-operative airway assistance(Day 0)
- post-operative pain(Day 0)
- remedial mask induction acceptance(Day 0)
- propofol dosage(Day 0)
- peri-operative blood pressure(Day 0)
- peri-operative heart rate(Day 0)
- Observer's Assessment of Alertness/Sedation(MOAA/S) Score(Day 0)
- patients' discomfort(up to 24 hours)
研究者
Yang Xudong
Chief of Department of Anesthesiology
Peking University