Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

Pia Jaeger, MD, PhD

Status: Enrolling

Conditions: Surgical Procedure, Unspecified

Treatments: Device: The NOL monitor (Pain Monitoring Device monitor-PMD200™)

Study type: Interventional

Funder types: Other

Identifiers

NCT05725382

NOL1-2022

Details and patient eligibility

About

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.

Full 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

Enrollment: 264 estimated patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 2 patient groups

NOL-guided remifentanil dosing

Experimental group

Description:

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

Treatment:

Device: The NOL monitor (Pain Monitoring Device monitor-PMD200™)

Standard care remifentanil dosing

No Intervention group

Description:

Remifentanil dosing will be administered according to standard care per institutional practice.