Mother's Recorded Voice: a Neglected Therapeutic Stance for Pediatric Postoperative Agitation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Pediatric anesthesia of emergence delirium (PAED) score
研究概览
简要总结
The aim of this study is to compare the efficacy of mother's recorded voice versus dexmedetomidine injection on postoperative agitation in children undergoing elective surgery.
详细描述
A written informed consent will be taken from the patients' legal guardians.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized and either randomly assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery) (Group M) or will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group D) or given the same volume of saline IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery) (Group C).To keep blinding, group M will be injected IV with the same volume of saline at the same 2 times as in groups D & C while in groups D & C, headphones will be putted as in group M at the same 2 times with no recorded voice.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (age 4-9 years)
- •American Society of Anesthesiologists physical status (ASA) I-II who will be listed for outpatient elective surgery under general anesthesia.
排除标准
- •Developmental delays
- •Neurological diseases
- •Hearing impairment
- •Maternal mutism
- •Absence of the mother
研究组 & 干预措施
Mother's recorded voice
Children will be exposed to the mother's voice.
干预措施: the mother's recorded voice (Behavioral)
Dexmedetomidine IV
Children will be given dexmedetomidine injection.
干预措施: Dexmedetomidine (Drug)
Saline placebo IV
Children will be given normal saline.
干预措施: saline 0.9% placebo (Other)
结局指标
主要结局
Pediatric anesthesia of emergence delirium (PAED) score
时间窗: 2 hours Postoperative
Emergence delirium (ED) will be measured by the pediatric anesthesia of emergence delirium (PAED).The scores for each of the five listed behaviours(makes eye contact with caregiver, actions are purposeful,aware of surroundings, restless and inconsolable) are added to achieve a total score (maximum score of 20). A score of \>12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
次要结局
- Face, Legs, Activity, Cry, and Consolability (FLACC) score(24 hours Postoperative)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University