Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

Launched by PIA JAEGER, MD, PHD · Feb 9, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a special monitor that measures pain levels can help doctors give a medicine called remifentanil to children during surgery. Remifentanil is an opioid, which means it helps manage pain, and this study aims to see if using the pain monitor can lead to less pain for children after surgery, compared to the usual care methods.

To be part of this study, children need to be between the ages of about 3 to 15 and scheduled for a surgery that requires pain management with opioids. Their guardians must be able to understand the study details and give their permission. Children who have certain health issues, such as heart problems or allergies to the study medications, or those who take other opioid medicines regularly, won't be able to participate. If they join, families can expect a carefully monitored experience that aims to improve pain management after surgery, helping their child recover more comfortably.

Gender

ALL

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