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NCT05725382
Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia
Conditions: Surgical Procedure, Unspecified
Sex: All
Ages: 3 Years – 16 Years
Phase: NA
Enrollment: 264
Sponsor: Pia Jaeger, MD, PhD
Location: Denmark
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 Criteria
Inclusion Criteria:American Society of Anesthesiology (ASA) class of 1-3Scheduled surgery requiring intraoperative opioid administrationPlanned maintenance anesthesia with propofol and remifentanilThe trial subject's custody holders' must be able to understand the trial protocol, risks, and benefits, and provide signed informed consentExclusion Criteria:Inability of the trial subject's custody holder to read or write DanishChildren 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 studyDaily intake of opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeksWeight < 10 kg
Source: ClinicalTrials.gov (NCT05725382). StuddyBuddy aggregates publicly available trial information.