Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

NCT05725382 | Unknown DMC

• 1 other identifier: NOL1-2022
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 4

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.

Conditions

Surgical Procedure, Unspecified

Keywords

Pediatric; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Opioid consumption at the PACU

  From extubation until discharge from PACU

• Perioperative opioid consumption

  From induction until extubation

• Opioid consumption after discharge from PACU and until the 48-h anesthesia followup

  From PACU discharge and until the 48-hours anesthesia followup

• 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.

• 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.

Other Outcomes (8)

• 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

  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

  Perioperatively

Study Arms (2)

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

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.

Interventions

The NOL monitor (Pain Monitoring Device monitor-PMD200™) DEVICE

NOL-guided perioperative remifentanil administration

Also known as: NOL-guided remifentanil dosing

NOL-guided remifentanil dosing

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pia Jaeger, MD, PhD: lead

Study Sites (4)

Department of Anaesthesia, The Center of Head and Orthopaedics, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Anaesthesia, The Juliane Marie Center, Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Department of Anaesthesia, Sjællands Universitetshospital, Køge

Køge, 4600, Denmark

NOT YET RECRUITING

Department of Anaesthesia, Vejle Sygehus

Vejle, 7100, Denmark

NOT YET RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pia Jæger, MD, PhD

  Department of Anaesthesia, The Juliane Marie Center, Rigshospitalet

  STUDY CHAIR

Central Study Contacts

Mette Lea Mortensen, MD

CONTACT

35452227; mette.lea.mortensen@regionh.dk

Pia Jæger, MD, PhD

CONTACT

35454016; pia.therese.jaeger@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Registrar

Model Details: Blinded, randomized, controlled multicenter trial with two parallel groups and a superiority design.

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 13, 2023
• Study Start: June 1, 2023
• Primary Completion: October 30, 2025
• Study Completion: November 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

DK (4)