Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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:
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IV paracetamol 15 mg/kg
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IV Ibuprofen 10 mg/kg, unless contraindicated
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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)
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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)
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Regional anesthesia may be provided at the discretion of the anesthetist
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IV ondansetron 100 μg/kg
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NOL-guided remifentanil dosing Remifentanil dosing will preferentially be guided by the NOL index, but blood pressure and heart rate will be monitored and considered concurrently. If the NOL index is > 25, remifentanil infusion will be increased. If the NOL index is < 10 the remifentanil infusion rate will be reduced |
Device: The NOL monitor (Pain Monitoring Device monitor-PMD200™)
NOL-guided perioperative remifentanil administration
Other Names:
|
| No Intervention: Standard care remifentanil dosing Remifentanil dosing will be administered according to standard care per institutional practice. |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Opioid consumption at the PACU [From extubation until discharge from PACU]
Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents
- 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
- 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.
- 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.
Other Outcome Measures
- 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.
- 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
- Mean NOL index [From the start of induction and until the time of extubation]
The mean NOL index during surgery
Eligibility Criteria
Criteria
Inclusion Criteria:
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American Society of Anesthesiology (ASA) class of 1-3
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Scheduled surgery requiring intraoperative opioid administration
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Planned maintenance anesthesia with propofol and remifentanil
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The trial subject's custody holders' must be able to understand the trial protocol, risks, and benefits, and provide signed informed consent
Exclusion Criteria:
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Inability of the trial subject's custody holder to read or write Danish
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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.
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Arrythmias, either known arrythmias preoperatively or arrythmias detected within the first minutes perioperatively (in which case the patient will be excluded post- randomization).
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Allergy to the medicines used in the study
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Daily intake of opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
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Weight < 10 kg
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 2 | Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark | 2100 | |
| 3 | Department of Anaesthesia, Sjællands Universitetshospital, Køge | Køge | Denmark | 4600 | |
| 4 | Department of Anaesthesia, Vejle Sygehus | Vejle | Denmark | 7100 |
Sponsors and Collaborators
- Pia Jaeger, MD, PhD
Investigators
- Study Chair: Pia Jæger, MD, PhD, Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NOL1-2022