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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NOL-guided remifentanil dosing | Experimental | Remifentanil dosing will preferentially be guided by the NOL index, but blood pressure and heart rate will be monitored and considered concurrently.
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| Standard care remifentanil dosing | No Intervention | Remifentanil dosing will be administered according to standard care per institutional practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The NOL monitor (Pain Monitoring Device monitor-PMD200™) | Device | NOL-guided perioperative remifentanil administration |
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| Measure | Description | Time Frame |
|---|---|---|
| First pain score assessed at the PACU | Pain at rest assessed using the Faces Pain Scale - Revised (0-100 mm). | Assessed at the first time the child is awake at the PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption at the PACU | Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PACU length of stay. | 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 |
| Postoperative nausea or vomiting |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mette Lea Mortensen, MD | Contact | 35452227 | 0045 | mette.lea.mortensen@regionh.dk |
| Pia Jæger, MD, PhD | Contact | 35454016 | 0045 | pia.therese.jaeger@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Pia Jæger, MD, PhD | Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Blinded, randomized, controlled multicenter trial with two parallel groups and a superiority design.
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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.
| 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 | 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. | 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. | Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge. |
| Postoperative 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. | Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge. |
Assessed as a dichotomous endpoint, as either presence or absence of nausea or vomiting at any time point, during the period.
| Will be assessed twice; 1) at the PACU and 2) from PACU discharge and until the 48-hour follow up. |
| Number of events of hemodynamic instability | Number of events of hemodynamic instability requiring drug or fluid administration perioperatively. | Perioperatively |
| Time to extubation | The time from anesthesia maintenance is stopped until the patient is extubated/LMA is removed | From anesthesia maintenance is stopped until the patient is extubated/LMA is removed |
| Parental satisfaction. | Parental satisfaction with anesthesia assessed on a numeric rating scale from 0 to 10. | Assessed at 48 hours postoperatively, for the entire period 0-48 hours postoperatively |
| Time where the NOL index value is > 25 | Time (minutes) where the NOL index value is > 25 | From the start of induction and until the time of extubation |
| Maximum NOL index | The highest NOL index during a 5-minute period at any time perioperatively | From the start of induction and until the time of extubation |
| Mean NOL index | The mean NOL index during surgery | From the start of induction and until the time of extubation |
| Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Department of Anaesthesia, Sjællands Universitetshospital, Køge | Not yet recruiting | Køge | 4600 | Denmark |
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| Department of Anaesthesia, Vejle Sygehus | Not yet recruiting | Vejle | 7100 | Denmark |
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