NCT05725382

Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Pia Jaeger, MD, PhD · Academic / Other
• Sex: All
• Age: 3 Years – 16 Years
• Healthy volunteers: Not accepted

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

Conditions

• Surgical Procedure, Unspecified

Interventions

Type	Name	Description
DEVICE	The NOL monitor (Pain Monitoring Device monitor-PMD200™)	NOL-guided perioperative remifentanil administration

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-10-30
• Completion: 2025-11-01
• First posted: 2023-02-13
• Last updated: 2023-08-24

Locations

4 sites across 1 country: Denmark