Surgical Procedure, Unspecified
Conditions
Keywords
Pediatric, Pain
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
Interventions
DEVICEThe NOL monitor (Pain Monitoring Device monitor-PMD200™)
NOL-guided perioperative remifentanil administration
Sponsors
Pia Jaeger, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patients and their relatives, outcome assessors, data analysts and PACU nurses will be blinded. However, the anesthesiologists and anesthesia nurses anesthetizing the child according to the NOL monitor/standard care cannot be blinded. The anesthesiologist and anesthesia nurses anesthetizing the child will not be involved in patient care after the patient leaves the theatre, nor in any clinical assessments, data collection or interpretation of adverse events.
Intervention model description
Blinded, randomized, controlled multicenter trial with two parallel groups and a superiority design.
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First pain score assessed at the PACU | Assessed at the first time the child is awake at the PACU | Pain at rest assessed using the Faces Pain Scale - Revised (0-100 mm). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative opioid consumption | From induction until extubation | 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. |
| Opioid consumption after discharge from PACU and until the 48-h anesthesia followup | From PACU discharge and until the 48-hours anesthesia followup | Total, cumulative, opioid consumption, calculated as IV morphine equivalents |
| Opioid consumption at the PACU | From extubation until discharge from PACU | Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents |
| FLACC pain scores at rest during the PACU stay | Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge. | Pain at rest assessed using the Face Legs, Activity, Cry and Consolability scale (FLACC, 0-10 points), calculated as area under the curve. |
| Postoperative agitation | Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge. | Postoperative agitation assessed using the WATCHA scale (0-4). The highest score at any time point will be used for the comparison between groups. |
| Faces Pain Scale - Revised scores at rest during the PACU stay | Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| PACU length of stay. | 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 | PACU length of stay. |
| Mean NOL index | From the start of induction and until the time of extubation | The mean NOL index during surgery |
| Postoperative nausea or vomiting | Will be assessed twice; 1) at the PACU and 2) from PACU discharge and until the 48-hour follow up. | Assessed as a dichotomous endpoint, as either presence or absence of nausea or vomiting at any time point, during the period. |
| Number of events of hemodynamic instability | Perioperatively | Number of events of hemodynamic instability requiring drug or fluid administration perioperatively. |
| Time to extubation | From anesthesia maintenance is stopped until the patient is extubated/LMA is removed | The time from anesthesia maintenance is stopped until the patient is extubated/LMA is removed |
| Parental satisfaction. | Assessed at 48 hours postoperatively, for the entire period 0-48 hours postoperatively | Parental satisfaction with anesthesia assessed on a numeric rating scale from 0 to 10. |
| Time where the NOL index value is > 25 | From the start of induction and until the time of extubation | Time (minutes) where the NOL index value is \> 25 |
| Maximum NOL index | From the start of induction and until the time of extubation | The highest NOL index during a 5-minute period at any time perioperatively |
Countries
Denmark
Contacts
Primary ContactMette Lea Mortensen, MD
Backup ContactPia Jæger, MD, PhD
Outcome results
None listed