Effects of Individualized Opioid Analgesia Versus Conventional Opioid Analgesia After Adenotonsillectomy in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 1
- 主要终点
- Desaturation events
研究概览
简要总结
The objective of this randomized clinical trial is to assess the safety and effectiveness of post-adenotonsillectomy analgesia with individualized opioid analgesia regime in children.
详细描述
Patients will be randomly assigned to individualized opioid analgesia regimen group or conventional opioid analgesia regimen group.
Intravenous 1μg/kg fentanyl is administered as a test in patients with spontaneous breath after sevoflurane induction. A positive result is defined as a decrease of more than 50% in spontaneous respiratory rate (rate after fentanyl test versus rate before fentanyl test). Otherwise it is defined as a negative result.
All the patients are given regular paracetamol and ibuprofen after surgery. The addition of rescue oral morphine is given as needed. The dose of oral morphine is determined according to the results of fentanyl test in the individualized group, while the patients in the conventional group are given the routine dose. The Faces Scale is used to assess analgesic effectiveness by parents from postoperative day 1 to day 10. If the Faces Scale score > 6, the child receive rescue oral morphine analgesia.
At the preoperative appointment, parents are provided with a pulse oximeter including oxygen saturation sensors to take home. The oxygen saturation per night during sleep will be monitored using the pulse oximeter by parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children, ASA physical status I or II, who is scheduled to undergo adenotonsillectomy will be recruited.
排除标准
- •Children with craniofacial deformities, neuromuscular diseases, mental retardation, body mass index > 30kg/m2 , or a recent history of opioid use are excluded.
研究组 & 干预措施
individualized opioid analgesia regimen group
The dose of oral morphine for patients in the individualized group is determined according to the results of fentanyl test.
干预措施: Individualized oral morphine (Drug)
conventional opioid analgesia regimen group
Patients in the conventional group are given routine dose of oral morphine.
干预措施: Conventional oral morphine (Drug)
结局指标
主要结局
Desaturation events
时间窗: from postoperative day 1 to day 10, each night
The oxygen saturation per night during sleep will be monitored using a pulse oximeter by the parents from postoperative Day 1 to Day 10. The research team will instruct parents on how to properly apply the oximeter to the child and repeat these measurements. The primary outcome measure is desaturation events during sleep per night.
次要结局
- Scores of Pain Scale (the Faces Scale)(every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day))
- Scores of Pain Scale (the Objective Pain Scale)(every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day))
- Tonsillar bleeding events(from postoperative day 1 to day 10)
- Adverse drug reactions(from postoperative day 1 to day 10)