NCT00834730已完成4 期
Comparison of N2O Inhalation and Ketamine IV Injection for Sedation in the Treatment of Laceration of Pediatric Patients.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The recovery time (from completion of laceration repair to recovery of mental state)
研究概览
简要总结
- Ketamine provides effective and relatively safe sedation analgesia for primary closure of lacerated pediatric patients
- However, deep sedation and adverse effects suggest the opportunity to develop alternative strategies
- We compared the efficacy and adverse effects of ketamine to those of N2O gas for analgesia and anxiolysis during primary repair of lacerated pediatric patients
详细描述
- There were 32 children who were randomly assigned
- Recovery times were markedly shorter in the N2O group compared with those in the ketamine group (median, 0.0 min (interquartile range [IQR], 0.0-4.0 min) vs. median, 21.5 min (IQR, 12.5-37.5 min), N2O vs. ketamine, respectively, p < 0.05)
- Sedation levels were deeper in the ketamine group than in the N2O group, but pain scales were comparable between groups
- No difference was observed in the satisfaction scores by physicians, parents, or nurses.
- N2O inhalation was preferable to injectable ketamine for pediatric patients because it is safe, allows for a faster recovery, maintains sufficient sedation time, and does not induce unnecessarily 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 36 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients with lacerated wound
排除标准
- •Contraindication of ketamine or N2O gas
- •A wound around eye and mouth
研究组 & 干预措施
Ketamine
Active Comparator
Ketamine 2mg/kg IV
干预措施: N2O gas vs ketamine (Drug)
N2O gas
Experimental
50%-70% N2O gas inhalation
干预措施: N2O gas vs ketamine (Drug)
结局指标
主要结局
The recovery time (from completion of laceration repair to recovery of mental state)
时间窗: before discharge
次要结局
- Satisfaction of parents and clinicians(before discharge)
- Sedation scale(before discharge)
- pain scale(before discharge)
- Side effects(during procedure and bedore discharge and 1day after discharge)
研究者
研究点 (1)
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