Intraoperative nociception and pain monitoring in preterm infants, neonates, infants, and young children undergoing general anesthesia
Conditions
Interventions
Group 1: Arm 1: Neonates including preterm infants (= 44 weeks postmenstrual age)
Arm 2: Infants (> 44 weeks postmenstrual age to = 3 months postnatal age)
Arm 3: Toddlers (> 3 months to = 2 years of
Sponsors
Klinik für Anästhesiologie und Intensivmedizin
Eligibility
Sex/Gender
All
Age
0 Years to 4 Years
Inclusion criteria
Inclusion criteria: Age 44 weeks postmenstrual age to = 3 months postpartum); Cluster III: toddlers (> 3 months to = 2 years); Cluster IV: children (> 2 years to < 5 years)) Surgery under general anesthesia with inhalational induction, airway management using a laryngeal mask airway, and caudal anesthesia (see anesthesia protocol) Oral and written informed consent obtained from both parents/legal guardians
Exclusion criteria
Exclusion criteria: Lack of German language proficiency of the parents/legal guardians Emergency surgery Preoperative analgesic therapy Preoperative treatment with anticholinergic medication Contraindications for PMD-200 (NOL sensor): Severe cardiac arrhythmias, including: supraventricular tachycardia atrial fibrillation atrial flutter ventricular fibrillation ventricular tachycardia cardiac arrest During cardiopulmonary resuscitation During cardioversion/defibrillation Contraindications for TetraGraph: Pre-existing neuromuscular disorders (e.g., myasthenia gravis, muscular dystrophy) History of stroke or cerebral infarction Use in close proximity to an MRI device No stimulation over the carotid sinus nerve or in patients with carotid sinus hypersensitivity No stimulation over the neck or mouth due to the risk of severe laryngeal and pharyngeal muscle spasms with potential airway obstruction and respiratory compromise No transthoracic stimulation, as electrical current passing through the heart may induce cardiac arrhythmias No transcranial stimulation No stimulation over swollen, infected, inflamed skin areas or skin lesions/rashes (e.g., phlebitis, thrombophlebitis, varicose veins) No stimulation over or near malignant lesions No stimulation in patients with suspected or diagnosed cardiac disease No stimulation in patients with suspected or diagnosed epilepsy No stimulation in menstruating patients or during pregnancy No stimulation in skin areas without normal sensation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ?NOL (NOL = Nociception Level Index, a multiparametric, dimensionless index for the assessment of nociception), defined as: ?NOL = NOLmax - NOLprestim where NOLmax represents the highest NOL value within 3 minutes after stimulus application and NOLprestim represents the NOL value immediately before stimulus application. The endpoint will be assessed for stimulation intensities of 10 mA, 30 mA, and 60 mA. Time of assessment: Assessment is performed intraoperatively after induction of general anesthesia, airway management, performance of caudal anesthesia, and achievement of predefined physiological target parameters. Measurements are performed twice: - before administration of systemic opioid analgesia - after standardized administration of remifentanil and an onset time of 3 minutes Data collection: NOL values are recorded continuously and non-invasively using the PMD-200™ NOL monitor. Standardized electrical nociceptive stimuli are applied using the TetraGraph system in a Latin-square randomized sequence. The exact time points of stimulus application are marked on the monitor. Data are exported postoperatively and analyzed statistically. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Increase in the Nociception Level Index (NOL) at any time during surgery as an indicator of potentially insufficient caudal anesthesia or inadequate systemic analgesia. - Correlation of intraoperatively measured NOL values with postoperative pain intensity in the recovery room, assessed using age-adapted pain assessment scales: Bernese Pain Scale for Neonates-Revised (BPSN-R) for neonates and preterm infants Kindliche Unbehagen- und Schmerzskala (KUSS) for infants and children up to 4 years of age Postoperative analgesic requirement within the first 24 hours after surgery, documented as: opioid requirement expressed as morphine equivalents (mg/24 h), NSAID and metamizole consumption (mg/24 h) - Incidence of postoperative nausea and vomiting (PONV) in the recovery room (binary endpoint: yes/no). - Incidence of emergence delirium in the recovery room, assessed using the Pediatric Anesthesia Emergence Delirium Scale (PAED scale). - Postoperative pain assessment by parents using the Parents’ Postoperative Pain Measure – German version (PPPM-D) within a maximum of 24 hours postoperatively. | — |
Countries
Germany
Contacts
Public ContactSebastian Schmid
Klinik für Anästhesiologie und Intensivmedizin
Outcome results
None listed