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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
264
NOL-guided perioperative remifentanil administration
Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet
Copenhagen, Denmark
RECRUITINGDepartment of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
RECRUITINGDepartment of Anaesthesia, Sjællands Universitetshospital, Køge
Køge, Denmark
First pain score assessed at the PACU
Pain at rest assessed using the Faces Pain Scale - Revised (0-100 mm).
Time frame: Assessed at the first time the child is awake at the PACU
Opioid consumption at the PACU
Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents
Time frame: From extubation until discharge from PACU
Perioperative opioid consumption
Total, cumulative, perioperative opioid consumption, calculated as IV remifentanil equivalents. The planned administration of morphine/fentanyl at the end of surgery will NOT be included.
Time frame: From induction until extubation
Opioid consumption after discharge from PACU and until the 48-h anesthesia followup
Total, cumulative, opioid consumption, calculated as IV morphine equivalents
Time frame: From PACU discharge and until the 48-hours anesthesia followup
Faces Pain Scale - Revised scores at rest during the PACU stay
Pain at rest, assessed using the Faces Pain Scale - Revised (Revised (0-100 mm), calculated as the area under the curve. If the child is sleeping, a pain score of 0 will be assigned.
Time frame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
FLACC pain scores at rest during the PACU stay
Pain at rest assessed using the Face Legs, Activity, Cry and Consolability scale (FLACC, 0-10 points), calculated as area under the curve.
Time frame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
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Department of Anaesthesia, Vejle Sygehus
Vejle, Denmark
NOT_YET_RECRUITINGPostoperative agitation
Postoperative agitation assessed using the WATCHA scale (0-4). The highest score at any time point will be used for the comparison between groups.
Time frame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.