Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 8
- 主要终点
- First pain score assessed at the PACU
研究概览
简要总结
The investigators aim to investigate whether administration of a short-acting opioid (remifentanil) guided by a pain monitor (nociceptive level monitor) during anesthesia, can reduce pain in children after surgery.
The investigators hypothesize that pain monitor-guided administration of remifentanil can reduce pain postoperatively compared with standard care.
详细描述
NOL-guided analgesia has not previously been assessed in children, and it is unknown whether this additional monitoring has any clinical benefits in a pediatric population.
In the present study the investigators aim to investigate whether administration of perioperative remifentanil guided by the CE-certified Pain Monitoring Device monitor-PMD200™, also called NOL-monitor, can reduce pain (primary endpoint), opioid consumption and agitation in children aged 3-16 years undergoing surgery with intravenous anesthesia.
The investigators hypothesize that NOL-guided perioperative remifentanil administration can reduce postoperative pain compared with standard clinical care (remifentanil dosing based on hemodynamic variables).
All patients will receive standard analgesia and antiemetic administered perioperatively:
- IV paracetamol 15 mg/kg
- IV Ibuprofen 10 mg/kg, unless contraindicated
- IV Morphine 25-100 μg/kg according to the extent of surgery and the departments' standard, administered 30 minutes before end of surgery (will not be included in the total perioperative or postoperative opioid consumption)
- In case of minor surgery, 1-2 μg/kg fentanyl, according to the department's standard, may be administered instead of morphine at the discretion of the anesthetist (will not be included in the total perioperative or postoperative opioid consumption)
- Regional anesthesia may be provided at the discretion of the anesthetist
- IV ondansetron 100 μg/kg
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)
盲法说明
The patients and their relatives, outcome assessors, data analysts and PACU nurses will be blinded. However, the anesthesiologists and anesthesia nurses anesthetizing the child according to the NOL monitor/standard care cannot be blinded. The anesthesiologist and anesthesia nurses anesthetizing the child will not be involved in patient care after the patient leaves the theatre, nor in any clinical assessments, data collection or interpretation of adverse events.
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiology (ASA) class of 1-3
- •Scheduled surgery requiring intraoperative opioid administration
- •Planned maintenance anesthesia with propofol and remifentanil
- •The trial subject's custody holders' must be able to understand the trial protocol, risks, and benefits, and provide signed informed consent
排除标准
- •Inability of the trial subject's custody holder to read or write Danish
- •Children who cannot cooperate to the study assessments based on the investigators' evaluation. This may be children with mental disorders, visual disturbances, hearing or speech impairment etc. interfering with assessments.
- •Arrythmias, either known arrythmias preoperatively or arrythmias detected within the first minutes perioperatively (in which case the patient will be excluded post- randomization).
- •Allergy to the medicines used in the study
- •Daily intake of opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
- •Weight < 10 kg
结局指标
主要结局
First pain score assessed at the PACU
时间窗: Assessed at the first time the child is awake at the PACU
Pain at rest assessed using the Faces Pain Scale - Revised (0-100 mm).
次要结局
- Opioid consumption at the PACU(From extubation until discharge from PACU)
- Opioid consumption after discharge from PACU and until the 48-h anesthesia followup(From PACU discharge and until the 48-hours anesthesia followup)
- Faces Pain Scale - Revised scores at rest during the PACU stay(Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.)
- Postoperative agitation(Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.)
- Perioperative opioid consumption(From induction until extubation)
- FLACC pain scores at rest during the PACU stay(Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.)
研究者
Pia Jaeger, MD, PhD
Senior Registrar
Rigshospitalet, Denmark