Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 16
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet
RECRUITING
Copenhagen
Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet
RECRUITING
Copenhagen
Department of Anaesthesia, Sjællands Universitetshospital, Køge
NOT_YET_RECRUITING
Køge
Department of Anaesthesia, Vejle Sygehus
NOT_YET_RECRUITING
Vejle
Contact Information
Primary
Mette Lea Mortensen, MD
mette.lea.mortensen@regionh.dk
35452227
Backup
Pia Jæger, MD, PhD
pia.therese.jaeger@regionh.dk
35454016
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 264
Treatments
Experimental: NOL-guided remifentanil dosing
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
No_intervention: Standard care remifentanil dosing
Remifentanil dosing will be administered according to standard care per institutional practice.
Related Therapeutic Areas
Sponsors
Leads: Pia Jaeger, MD, PhD