Using a pain monitor to guide opioid dosing in children during anesthesia

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

This study is testing if using a pain monitor to guide opioid dosing during anesthesia can help reduce pain and agitation in children aged 3-16 after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 3 Years to 16 Years
• Sex: All
• Sponsor: Rigshospitalet, Denmark (other)
• Locations: 4 sites (Copenhagen and 3 other locations)
• Trial ID: NCT05725382 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of using a nociception level monitor to guide the administration of remifentanil, a short-acting opioid, during general anesthesia in children aged 3-16 years. The goal is to determine if this approach can reduce postoperative pain, opioid consumption, and agitation compared to standard care. Participants will receive standard analgesia and antiemetics alongside the monitored opioid dosing. The study aims to provide insights into the clinical benefits of nociception level-guided analgesia in a pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 3-16 years scheduled for surgery requiring intraoperative opioid administration.

Not a fit: Patients with mental disorders or impairments that affect cooperation, as well as those with known arrhythmias or allergies to the study medications, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved pain management and reduced opioid use in children after surgery.

How similar studies have performed: While nociception level-guided analgesia has not been previously assessed in children, similar approaches in adults have shown promising results.

Eligibility criteria

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

Where this trial is running

Copenhagen and 3 other locations

• Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
• Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (RECRUITING)
• Department of Anaesthesia, Sjællands Universitetshospital, Køge — Køge, Denmark (NOT_YET_RECRUITING)
• Department of Anaesthesia, Vejle Sygehus — Vejle, Denmark (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Mette Lea Mortensen, MD

Conditions: Surgical Procedure, Unspecified, Pediatric, Pain