Surgical Procedure, UnspecifiedNCT05725382
Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia
A study testing The NOL monitor (Pain Monitoring Device monitor-PMD200™) in people with Surgical Procedure, Unspecified, run by Pia Jaeger, MD, PhD at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- The NOL monitor (Pain Monitoring Device monitor-PMD200™)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 4 sitesDenmark
- Study dates
- 1 Jun 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites, 4 recruiting
- Recruiting
Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet
Copenhagen, 2100
Morten Bøttger, MD, MMD, morten.boettger@regionh.dk
- Recruiting
Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Mette Lea Mortensen, MD, mette.lea.mortensen@regionh.dk
Arash Afshari, MD, PhD
- Not yet recruiting
Department of Anaesthesia, Sjællands Universitetshospital, Køge
Køge, 4600
Casper H Jørgensen, MD, PhD, chj@regionsjaelland.dk
- Not yet recruiting
Department of Anaesthesia, Vejle Sygehus
Vejle, 7100
Nick P Steen, MD, nick.phaff.steen@rsyd.dk
About this study
Official title: Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial
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.
Read the 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
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- The NOL monitor (Pain Monitoring Device monitor-PMD200™)
- Keywords
- Pediatric, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The NOL monitor (Pain Monitoring Device monitor-PMD200™)Device
Also called NOL-guided remifentanil dosing
NOL-guided perioperative remifentanil administration
| Study group | Role | What they receive |
|---|---|---|
| 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.
* If the NOL index is > 25, remifentanil infusion will be increased.
* If the NOL index is < 10 the remifentanil infusion rate will be reduced Receives: Device: The NOL monitor (Pain Monitoring Device monitor-PMD200™) |
| Standard care remifentanil dosing | No intervention | Remifentanil dosing will be administered according to standard care per institutional practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pain score assessed at the PACU
Pain at rest assessed using the Faces Pain Scale - Revised (0-100 mm).
Measured: Assessed at the first time the child is awake at the PACU
Secondary outcomes (6)
Opioid consumption at the PACU
Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jun 2023
- Primary completion30 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, randomized, controlled multicenter trial with two parallel groups and a superiority design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pia Jaeger, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pia Jaeger, MD, PhD, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pia Jæger, MD, PhD, Study chair, Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725382
- Sponsor's protocol ID
- NOL1-2022
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05725382
- Acronym / sponsor ID
- NOL1-2022
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- Pediatric, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Pia Jaeger, MD, PhDUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Blinded, randomized, controlled multicenter trial with two parallel groups and a superiority design.
| Arm | Type | Receives |
|---|---|---|
| NOL-guided remifentanil dosing | Experimental | Device: The NOL monitor (Pain Monitoring Device monitor-PMD200™)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 |
| Standard care remifentanil dosing | No intervention | –Remifentanil dosing will be administered according to standard care per institutional practice. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The NOL monitor (Pain Monitoring Device monitor-PMD200™)Also: NOL-guided remifentanil dosingNOL-guided perioperative remifentanil administration | Device | NOL-guided remifentanil dosing |
Primary outcome
First pain score assessed at the PACU
Time frame: 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).
6 secondary outcomes
Opioid consumption at the PACU
Time frame: From extubation until discharge from PACU
Perioperative opioid consumption
Time frame: From induction until extubation
Opioid consumption after discharge from PACU and until the 48-h anesthesia followup
Time frame: From PACU discharge and until the 48-hours anesthesia followup
Faces Pain Scale - Revised scores at rest during the PACU stay
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
Time frame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
Postoperative agitation
Time frame: Assessed at 15, 30, 45 and 60 minutes after arrival at the PACU, and thereafter every 30 minutes until discharge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pia Jæger, MD, PhD study chair
Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The NOL monitor (Pain Monitoring Device monitor-PMD200™) in people with Surgical Procedure, Unspecified, run by Pia Jaeger, MD, PhD at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mette Lea Mortensen, MD (35452227 ext. 0045, mette.lea.mortensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pain score assessed at the PACU (time frame: Assessed at the first time the child is awake at the PACU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.