Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia
- Conditions
- Surgical Procedure, Unspecified
- Interventions
- Device: The NOL monitor (Pain Monitoring Device monitor-PMD200™)
- Registration Number
- NCT05725382
- Lead Sponsor
- Pia Jaeger, MD, PhD
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 264
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NOL-guided remifentanil dosing The NOL monitor (Pain Monitoring Device monitor-PMD200™) Remifentanil dosing will preferentially be guided by the NOL index, but blood pressure and heart rate will be monitored and considered concurrently. * If the NOL index is \> 25, remifentanil infusion will be increased. * If the NOL index is \< 10 the remifentanil infusion rate will be reduced
- Primary Outcome Measures
Name Time Method First pain score assessed at the PACU 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).
- Secondary Outcome Measures
Name Time Method Opioid consumption at the PACU From extubation until discharge from PACU Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents
Opioid consumption after discharge from PACU and until the 48-h anesthesia followup From PACU discharge and until the 48-hours anesthesia followup Total, cumulative, opioid consumption, calculated as IV morphine equivalents
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. Pain at rest, assessed using the Faces Pain Scale - Revised (Revised (0-100 mm), calculated as the area under the curve. If the child is sleeping, a pain score of 0 will be assigned.
Postoperative agitation Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge. Postoperative agitation assessed using the WATCHA scale (0-4). The highest score at any time point will be used for the comparison between groups.
Perioperative opioid consumption From induction until extubation Total, cumulative, perioperative opioid consumption, calculated as IV remifentanil equivalents. The planned administration of morphine/fentanyl at the end of surgery will NOT be included.
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. Pain at rest assessed using the Face Legs, Activity, Cry and Consolability scale (FLACC, 0-10 points), calculated as area under the curve.
Trial Locations
- Locations (4)
Department of Anaesthesia, Sjællands Universitetshospital, Køge
🇩🇰Køge, Denmark
Department of Anaesthesia, Vejle Sygehus
🇩🇰Vejle, Denmark
Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet
🇩🇰Copenhagen, Denmark
Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenhagen, Denmark