Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia With Ketamine-midazolam Combination: A Prospective Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Pediatric Anesthesia Emergence Delirium (PAED) score
研究概览
简要总结
Investigators evaluated the effect of intranasal ketamine or alfentanil addition to oral midazolam for prevention of emergence agitation.Seventy-eight, 1-8 year-old children, undergoing urological surgery with sevoflurane anesthesia was included in the study. All the children received oral midazolam 0.5 mg/kg 40 minutes before anesthesia induction then enrolled to one of the study groups, randomly. Ketamine group (Group MK; n=26) patients were given 2mg/kg intranasal ketamine whereas, alfentanil group (Group MA; n=25) were given 10microgram/kg intranasal alfentanil 8-10 min before the induction of anesthesia. Saline group (Group MS; n=27) received intranasal isotonic saline.Parental separation, mask acceptance were evaluated with a 4- point scale. Emergence agitation was evaluated with Pediatric Anesthesia Emergence Delirium score.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- 8 years
- •American Society of Anesthesiologist (ASA) I-II,
- •Patients undergoing procedures below the umbilicus
排除标准
- •cardiac diseases
- •pulmonary diseases
- •hepatic diseases
- •renal diseases
- •psychological or emotional disorders
研究组 & 干预措施
midazolam and ketamine
Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
干预措施: ketamine (Drug)
midazolam and alfentanil
Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
干预措施: midazolam (Drug)
midazolam and alfentanil
Midazolam 0.5mg/kg (oral) Alfentanil 10 microgram/kg (oral)
干预措施: alfentanil (Drug)
midazolam and ketamine
Midazolam 0.5mg/kg (oral) Ketamine 2mg/kg (intranasal)
干预措施: midazolam (Drug)
midazolam
Midazolam 0.5mg/kg
干预措施: midazolam (Drug)
结局指标
主要结局
Pediatric Anesthesia Emergence Delirium (PAED) score
时间窗: 7 months
Emergence agitation was evaluated using the Pediatric Anesthesia Emergence Delirium (PAED) score
次要结局
- Mask acceptance(7 months)
- Parental separation score(7 months)
研究者
Sevgi Bilgen
Yeditepe University
Yeditepe University Hospital