A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Postoperative agitation score
研究概览
简要总结
The aim of this study is to observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and postoperative wound recovery rate.
Participants will be randomly allocated to two groups:a lollipop sucking group (Group A) and a control group (Group B), Two groups of children were sent to the recovery room (PACU) for observation after extubation . Group A patients were given lollipops for sucking after waking up, while Group B received routine nursing treatment.
The goal of this clinical trial is to explore whether lollipops have advantages in early postoperative feeding and alleviating postoperative agitation in children, and to provide reliable clinical evidence for the consumption of lollipops after surgery.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who choose to have adenotonsillectomy surgery
- •the American Society of Anesthesiologists (ASA) physical status ranked I-II
- •competent to provide informed consent
排除标准
- •psychiatric disorders
- •upper respiratory tract infection
- •high risk of reflux aspiration
- •carbohydrate malabsorption syndrome and other endocrine or genetic metabolic diseases (contraindications of lollipop ingredients)
结局指标
主要结局
Postoperative agitation score
时间窗: Time Frame: intraoperative period,10 minutes-1 hours
Postoperative agitation score will be recorded at 6 time points, including the time of entering the recovery room (Time 0), when the lollipop is given (Time 1), when the lollipop is given for 10 minutes(Time 2), when the lollipop is given for 20 minutes(Time 3), when the lollipop is given for 30 minutes(Time 4) and leave the recovery room (T5).
Incidence of nausea and vomiting
时间窗: Postoperative 1 minute-5hours
Incidence of nausea and vomiting will be recorded during the time of the recovery room and four hours after returning to the ward .
次要结局
- the time of leaving the recovery room and the hospital(Postoperative 1 hour - 3days)
- family satisfaction(Postoperative 5 hours)
- Spo2(Postoperative 1 minute - 5hours)
- other adverse reactions(Postoperative 10 minutes - 3days)
研究者
Li Na
Deputy Chief Physician
Maternal and Child Health Hospital of Hubei Province