Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

Surgical Procedure, Unspecified Clinical Trial

Official title:

Can Nociception Level-guided Remifentanil Dosing Reduce Postoperative Pain in Children During General Anesthesia: A Blinded, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725382
• Other study ID #: NOL1-2022
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: November 1, 2025

Study information

• Verified date: August 2023
• Source: Rigshospitalet, Denmark
• Contact: Mette Lea Mortensen, MD
• Phone: 35452227
• Email: mette.lea.mortensen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

The investigators hypothesize that pain monitor-guided administration of remifentanil can reduce pain postoperatively compared with standard care.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: November 1, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Device:
• The NOL monitor (Pain Monitoring Device monitor-PMD200™)
NOL-guided perioperative remifentanil administration

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet	Copenhagen
Denmark	Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet	Copenhagen
Denmark	Department of Anaesthesia, Sjællands Universitetshospital, Køge	Køge
Denmark	Department of Anaesthesia, Vejle Sygehus	Vejle

Sponsors (1)

Lead Sponsor	Collaborator
Pia Jaeger, MD, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Postoperative nausea or vomiting	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.
Other	Number of events of hemodynamic instability	Number of events of hemodynamic instability requiring drug or fluid administration perioperatively.	Perioperatively
Other	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
Other	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
Other	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
Other	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
Other	Mean NOL index	The mean NOL index during surgery	From the start of induction and until the time of extubation
Primary	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
Secondary	Opioid consumption at the PACU	Total, cumulative, opioid consumption, calculated as IV fentanyl equivalents	From extubation until discharge from PACU
Secondary	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.	From induction until extubation
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.