Intranasal Dexmedetomidine Versus Oral Midazolam Premedication for Postoperative Negative Behavior Changes in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Incidence of postoperative negative behavior changes
研究概览
简要总结
The goal of this clinical trial is to learn the effect of dexmedetomidine premedication in postoperative negative behavior changes in children compared to midazolam premedication. It will also learn about the effect of dexmedetomidine and midazolam in emergence delirium. The main questions are:
- Dose dexmedetomidine lower the incidence of postoperative negative behavior changes compared to midazolam?
- Dose dexmedetomidine lower the incidence of emergence delirium compared to midazolam? Researchers will compare dexmedetomidine to midazolam (a common pediatric premedication) to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.
Participants will:
- Take intranasal dexmedetomidine or oral midazolam or placebo (a look-alike substance that contains no drug) premedication
- Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 3, 7, and 30
详细描述
Due to the fear of being separated from parents, fear of venipuncture, and facing unfamiliar operating room environment, children have different degrees of anxiety before surgery. Preoperative anxiety can lead to strong stress response and increase the incidence of emergence delirium. It can even cause psychological trauma and affect children's physical and mental health growth. The study showed that preoperative anxiety was positively correlated with the incidence of emergence delirium and postoperative negative behavior change, and emergence delirium was a risk factor for postoperative negative behavior in children.
Currently, midazolam is the most commonly used sedative drug to relieve preoperative anxiety in children. Midazolam has anterograde amnesia effect, reducing the occurrence of intraoperative awareness, and alleviating psychological trauma and memory of malignant stimulation in children. Dexmedetomidine is a highly selective α2 adrenergic agonist with anxiolytic, sedative, and analgesic properties. Our previous study found that preoperative administration of dexmedetomidine can reduce the incidence of emergence delirium in children compared with midazolam However, no clinical studies have directly compared the effects of dexmedetomidine and midazolam premedication on postoperative negative behavior change in children.
This prospective randomized controlled trial was conducted to compare the effects of dexmedetomidine and midazolam premedication on preoperative anxiety, the incidence of postoperative delirium, and postoperative negative behavior changes in children to provide a reference for optimizing clinical anesthesia medication regimens.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •ASA physical status I or II;
- •Aged 2-5 years;
- •Scheduled for elective tonsillectomy and (or) adenoidectomy.
排除标准
- •Parents refusing to allow their children to participate;
- •Intake of sedative or analgesic medication within 48 hours before surgery;
- •Developmental delay;
- •Body mass index > 30 kg/m2;
- •Allergy to study drugs;
- •Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;
- •Any other conditions that precluded study inclusion.
研究组 & 干预措施
Placebo group
Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg.
干预措施: normal Saline (Drug)
Placebo group
Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral sweet solution 0.25 mL/kg.
干预措施: Glucose solution (Drug)
Midazolam group
Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.
干预措施: Midazolam (Drug)
Dexmedetomidine group
Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg.
干预措施: Glucose solution (Drug)
Midazolam group
Participants were premedicated with intranasal 0.9% saline 0.02 mL/kg and oral midazolam 0.5 mg/kg.
干预措施: normal Saline (Drug)
Dexmedetomidine group
Participants were premedicated with intranasal dexmedetomidine 2 μg/kg and oral sweet solution 0.25 mL/kg.
干预措施: Dexmedetomidine Hydrochloride (Drug)
结局指标
主要结局
Incidence of postoperative negative behavior changes
时间窗: Day 7 postoperatively
Postoperative negative behavior changes will be assessed using the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS).
次要结局
- Incidence of emergence delirium(Within 30 min after extubation)
- Length of postanesthesia care unit stay(Up to 60 minutes postoperatively)
- Emergence time(About up to 30 minutes postoperatively)
- Preoperative anxiety(Before the intervention in holding area)
- Incidence of postoperative negative behavior changes(Day 30 postoperatively)
- Parental satisfaction(Postoperative day 1)
- Incidence of adverse events(Up to 24 hours postoperatively)
- Parental separation anxiety(After intervention 30 minutes)
- Postoperative pain intensity(After extubation 10, 20, 30 min, and postoperative 1 day)
- Incidence of postoperative negative behavior changes(Day 1 postoperatively)
- Incidence of postoperative negative behavior changes(Day 3 postoperatively)
研究者
Yao Yusheng
Clinical Professor
Fujian Provincial Hospital