Effects of Different Premedication on Preoperative Sedation and Postoperative Agitation in Children Undergoing Ophthalmic and Otorhinolaryngologic Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Sedation
研究概览
简要总结
The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group.
Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium [PAED] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.
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
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •a recent history of upper respiratory tract infection, a known allergy to dexmedetomidine or midazolam, inability to understand the consent process or parental refusal.
研究组 & 干预措施
placebo
no premedication
干预措施: Saline (Drug)
oralmidazolam
0.5 mg/kg oral midazolam group
干预措施: midazolam (Drug)
intravenous midazolam
0.05 mg/kg intravenous injection midazolam group
干预措施: midazolam (Drug)
dexmedetomidine
2.5µg/kg intranasal dexmedetomidine group
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
Sedation
时间窗: 30 minutes after premedication
1. Rarely awake, needs shaking or shouting to wake up 2. Asleep, eyes closed, wakes up when called softly or lightly touched 3. Sleepy but eyes open spontaneously 4. Awake 5. Agitated
Emotional state
时间窗: 0 minutes after facemask application
1. Calm 2. Apprehensive, not smiling, tentative behaviour, withdrawn 3. Crying 4. Thrashing, crying with movement of arms and legs, resisting
次要结局
未报告次要终点
