Clinical trial NCT05725382: Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia
Official title: Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: Pediatric
Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 264
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, randomized, controlled multicenter trial with two parallel groups and a superiority design.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

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

Primary outcomes:
measure: First pain score assessed at the PACU
timeFrame: Assessed at the first time the child is awake at the PACU
Secondary outcomes:
measure: Opioid consumption at the PACU
timeFrame: From extubation until discharge from PACU
measure: Perioperative opioid consumption
timeFrame: From induction until extubation
measure: Opioid consumption after discharge from PACU and until the 48-h anesthesia followup
timeFrame: From PACU discharge and until the 48-hours anesthesia followup
measure: Faces Pain Scale - Revised scores at rest during the PACU stay
timeFrame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
measure: FLACC pain scores at rest during the PACU stay
timeFrame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
measure: Postoperative agitation
timeFrame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
Other outcomes:
measure: PACU length of stay.
timeFrame: Assessed as time from extubation (in case there is a wait for a PACU bay) and until PACU discharge readiness, defined as the time the participant fulfils local discharge criteria
measure: Postoperative nausea or vomiting
timeFrame: Will be assessed twice; 1) at the PACU and 2) from PACU discharge and until the 48-hour follow up.
measure: Number of events of hemodynamic instability
timeFrame: Perioperatively
measure: Time to extubation
timeFrame: From anesthesia maintenance is stopped until the patient is extubated/LMA is removed
measure: Parental satisfaction.
timeFrame: Assessed at 48 hours postoperatively, for the entire period 0-48 hours postoperatively
measure: Time where the NOL index value is > 25
timeFrame: From the start of induction and until the time of extubation
measure: Maximum NOL index
timeFrame: From the start of induction and until the time of extubation
measure: Mean NOL index
timeFrame: From the start of induction and until the time of extubation
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet
city: Køge
country: Denmark
facility: Department of Anaesthesia, Sjællands Universitetshospital, Køge
city: Vejle
country: Denmark
facility: Department of Anaesthesia, Vejle Sygehus
Study officials:
affiliation: Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet
name: Pia Jæger, MD, PhD
role: STUDY_CHAIR
References: