The Effects of Esketamine Sedation Compared With Fentanyl Sedation in Pediatric Dental Patients: A Double Blind, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Midazolam use
研究概览
简要总结
Since the 1970s, ketamine has been used in clinical anesthesia treatment. Compared with ketamine, esketamine has a higher clearance rate, so it has a shorter recovery time after anesthesia. This feature also makes ketamine more suitable for pediatric dental patients.The purpose of this study was to investigate and compare the efficacy of esketamine sedation and fentanyl sedation in pediatric dental patients
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
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-14 years old.
- •Oral out-patient sedative treatment in our hospital.
- •BMI between 18 to 30 kg/m
- •④. ASA: I-II degree. ⑤. Sign the informed consent.
排除标准
- •Patients who are allergic to esketamine, opioids, propofol, or have contraindications for these drug use.
- •Patients with mental illness or who are unable to cooperate.
- •Patients who have abnormal reaction to midazolam. ④. Patients who suffer from Apnea. ⑤. Patients who refuse to sign informed consent. ⑥. Patients who participated in other clinical trials within 4 weeks.
研究组 & 干预措施
Fentanyl group
The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.
干预措施: Fentanyl (Drug)
Fentanyl group
The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.
干预措施: Midazolam (Drug)
Esketamine group
The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.
干预措施: Esketamine (Drug)
Esketamine group
The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as "Anesthesia inducer". Midazolam 0.05mg/kg+ "Anesthesia inducer" was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg.
干预措施: Midazolam (Drug)
结局指标
主要结局
Midazolam use
时间窗: Day 0
The total use of midazolam
Hypoxemia
时间窗: Day 0
The incidence of intraoperative hypoxemia (Spo2\<92%)
次要结局
- Successful sedation(Day 0)
- Agitation and delirium(Day 0)
- Propofol requiring(Day 0)
- Recall of intraoperative events(Day 0)
- Respiratory depression(Day 0)
- The time for Modified Observer Assessment of Sedation Score(MOAA/S)>4(Day 0)
- Directional force recovery time(Day 0)
- Circulatory fluctuation(Day 0)
- Time of successful sedation(Day 0)
- MOAA/S score in recovery room(Day 0)
- Treatment comfort score(Day 0)
- The incidence of complications(Day 1)
- Visual Analogue Scale(VAS) of pain in recovery room(Day 0)
研究者
Yang Xudong
Chief of Department of Anesthesiology
Peking University