The Effect of Three Different Interventions on the Recovery Agitation and Delirium in the Pacu Pediatric Patients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Emergence agitation
研究概览
简要总结
Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .
详细描述
Compare the effects of
0.5 mg/kg oral midazolam,
watching film "Suko is being operated 'animation film (http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) and
playing a game named "fishing games" on postoperative emergency delirium by PAED (post anestesic emergency delirium) scale at PACU at arrive and every 5 minutes for 15 minutes after adenotonsillectomy.
Investigators also evaluated "Basic and 20 minutes after pharmacologic and nonpharmacolgic premedications on participitans anxiety by Modified Yale Preoperative Anxiety Scale m-YPAS scores"
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients
- •Elective surgery
- •Adenotonsillectomi
排除标准
- •Cronicdesease
- •Mental retarde
- •Hearing and visual impaired
- •Prematurite
研究组 & 干预措施
Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor
To prevent emergence agitation patient premedicated by watching a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).
干预措施: Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor (Other)
Play game (PC fishing game)
To prevent emergence agitation patient premedicated by playing a simple PC game (fishing game) At the end of sugery patients postoperatif emergence agitation evaluated PAED(pediatric anesthesia emergence delirium scale).
干预措施: Play game (PC fishing game) (Other)
Oral midazolam (Demizolam®)
To prevent emergence agitation patient premedicated by 0.5 mg oral midazolam At the end of sugery patients postoperatif emergence agitation evaluated by PAED(pediatric anesthesia emergence delirium scale).
干预措施: Oral midazolam (Other)
结局指标
主要结局
Emergence agitation
时间窗: Postoperative every 5 minutes for 15 minutes
Emergence agitation will be evaluated by PAED (pediatric anesthesia emergence dellirium).The PAED scale consists of five behaviors, each of which is rated on a five-level scale with a score of zero to four. The scores are added to achieve a total scale score (maximum value is 20). The score above 12 is significant for post operative emergence agitation.
次要结局
- preoperative anxiety(20 minutea after premedications.)
- Post operative pain(Postoperative every 5 minutes for 15 minutes)
- Mean arteriel pressure(Postoperative every 5 minutes for15 minutes)
- Heart rate(Postoperative every 5 minutes for15 minutes.)
研究者
Reyhan Polat
Associate Profesor
Diskapi Yildirim Beyazit Education and Research Hospital