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

See also
Status	Clinical Trial	Phase
Completed	`NCT03299920` - Opioid Consumption After Knee Arthroscopy	N/A
Completed	`NCT04061629` - Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children
Not yet recruiting	`NCT03213548` - Aesthetic and Functional Results of Alar Base Modifications in Rhinoplasty	N/A
Completed	`NCT06164158` - Role of Procedural Videos in Teaching the Surgery Residents	N/A
Recruiting	`NCT03854669` - Experimental Pain Reporting Accuracy and Clinical Post-operative Pain	N/A
Active, not recruiting	`NCT03776591` - Open D3 Right Hemicolectomy Compared to Laparoscopic CME for Right Sided Colon Cancer	N/A
Completed	`NCT04332679` - Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes	N/A
Completed	`NCT03305666` - Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures	Phase 4
Completed	`NCT05008107` - Virtual Reality as a Perioperative Teaching Tool for Families	N/A
Terminated	`NCT02399111` - A Trial to Evaluate Negative Pressure Incision Management System for Groin Wounds in Vascular Surgery Patients	N/A
Terminated	`NCT00753766` - Multifactorial Pre-operative Intervention in Diabetes Mellitus	N/A
Active, not recruiting	`NCT03684720` - Using 'Guided-Discovery-Learning' to Optimize and Maximize Transfer of Surgical Simulation	N/A
Recruiting	`NCT04134975` - Evaluation of the Contribution of Intraoperative Scans Coupled With the Navigation for the Precision of the Positioning of the Pedicle Screws During a Lumbar Spine Surgery: a Prospective Randomised Study	N/A
Completed	`NCT06148701` - Preoperative Anesthesia Automatic System:a Retrospective Cohort Study
Active, not recruiting	`NCT04202874` - A Trial Comparing Surgeon-administered TAP Block With Placebo After Midline Laparotomy in Gynecologic Oncology	Phase 3
Completed	`NCT05428579` - Status of Surgical Resection and Histologic Subtype as Predictors of Local Recurrence in Retroperitoneal Liposarcoma
Completed	`NCT02626546` - Predictors, Risk Factors and Outcome Following Major Surgery
Recruiting	`NCT06278610` - Pelvic Exenteration and Laterally Extended Pelvic Resection
Recruiting	`NCT05044832` - Decreasing Emergence Agitation With Personalized Music	N/A
Completed	`NCT04327895` - Surgery in Context of Terrorist Attack : a Survey of French Surgeons

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