Nociception Level-guided Remifentanil Dosing in Children During General

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Surgical Procedure, Unspecified

Clinical Trial Details

NCT number	NCT05725382
Study type	Interventional
Source	Rigshospitalet, Denmark
Contact	Mette Lea Mortensen, MD
Phone	35452227
Email	mette.lea.mortensen@regionh.dk
Status	Recruiting
Phase	N/A
Start date	June 1, 2023
Completion date	November 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Nociception Level-guided Remifentanil Dosing in Children During General Anesthesia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms