Influence of 0.75% Ropivacaine Topicalization on Emergence Agitation in Preschool-aged Children Undergoing Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 主要终点
- Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
研究概览
简要总结
Emergence agitation (EA) is highly prevalent in children after surgery. Risk factors for EA are Eye, nose and throat (ENT) surgery, preoperative anxiety, postoperative pain. There are several preventive strategies but none of them completely prevent EA.
Topical application of ropivacaine can reduce post-tonsillectomy pain. Therefore, it might reduce the incidence of postoperative EA.
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 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of anesthesiologist physical status class I/II
- •tonsillectomy or adenotonsillectomy under general anesthesia
排除标准
- •obstructive sleep apnea
- •developmental delay attention deficit hyperactivity disorder, allergy to local anesthetics, convulsion disorder
研究组 & 干预措施
Normal Saline
1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
干预措施: normal saline (Drug)
Ropivacaine
1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
干预措施: ropivacaine (Drug)
结局指标
主要结局
Paediatric anesthesia emergence delirium scale (PAED) score at PACU admission
时间窗: 1 min after postanesthesia care unit (PACU) admission
PAED score is assessed
次要结局
- Face legs activity cry consolability (FLACC) score(1 min after postanesthesia care unit (PACU) admission)
- FLACC score 20 min after PACU admission(20 min after postanesthesia care unit (PACU) admission)
- PAED score 30 min after PACU admission(30 min after postanesthesia care unit (PACU) admission)
- PAED score 10 min after PACU admission(10 min after postanesthesia care unit (PACU) admission)
- FLACC score 10 min after PACU admission(10 min after postanesthesia care unit (PACU) admission)
- PAED score 20 min after PACU admission(20 min after postanesthesia care unit (PACU) admission)
- FLACC score 30 min after PACU admission(30 min after postanesthesia care unit (PACU) admission)
研究者
Go Un Roh
Clinical assistant professor, primary investigator
Ajou University School of Medicine