ABSTRACT
Contexto: La analgesia en neonatos aún es controvertida, se debe conocer la farmacodinamia y farmacocinética, interacciones entre drogas y exige una profunda comprensión sobre la fisiopatología que causa el dolor. El manejo del dolor es prioridad y coadyuva al tratamiento en terapia intensiva neonatal, basado en: reducción de procedimientos dolorosos, uso de medidas farmacológicas como no farmacológicas y uso de escalas de evaluación clínica del dolor. Propósito: Este trabajo enfocará al Paracetamol y Fentanilo, sus beneficios y contraindicaciones, en pacientes neonatos posquirúrgicos aliviando también el estrés hospitalario (respuesta neuroendocrina y metabólica), mejor acoplamiento a maniobras invasivas. Sujeto y Método: Es un estudio epidemiológico, descriptivo, transversal, con dos cohortes. Se evaluará efectividad del Paracetamol y Fentanilo, administradas por vía venosa, en neonatos posquirúrgicos. Se dividieron los pacientes en dos grupos en forma aleatoria, el universo de pacientes será tomado en el tiempo determinado de estudio (6 meses); el Grupo I recibió Paracetamol venoso, 12 mg/kg cada 6 horas; el grupo II, recibió Fentanilo a dosis de 2 mcgr/kg cada 6 horas. Se describen las variaciones hemodinámicas, nivel de dolor con la escala NIPS (Neonatal Infant Pain Scale) y complicaciones que puedan presentarse con cada medicamento. Resultados: No se evidenció significativamente su efectividad entre ambas, sin embargo, Fentanilo demostró mejor efecto analgésico en dolor moderado a severo.
Background: The analgesia in neonates is still controversial, we must know the pharmacodynamics and pharmacokinetics, drugs interactions a deep understanding of the pain's pathophysiology. The management of pain is a priority and contributes to the treatment in neonatal intensive care, based on reduction of painful procedures, use of pharmacological and non-pharmacological measures and use of clinical pain assessment scales. Methods: The patients were divided in two groups in a random way, the universe of patients will be taken in the determined time of study (4 months); Group I received paracetamol, venous, 15 mg / kg every 6 hours; Group II received Fentanyl at a dose of 2 mcgr / kg every 6 hours. The hemodynamic variations, pain level with the NIPS scale (Neonatal Infant Pain Scale), its benefits and contraindications, in post-surgical neonatal patients also relieving hospital stress (neuroendocrine and metabolic response), better coupling to invasive maneuvers, and complications that may occur with each medication are described, the hemodynamic variables will be taken before (either at the patient's admission or 15 minutes before their surgery), during its therapeutic effect, and after administration (4 hours after administration). Results: There was no significant evidence of effectiveness between the two, however, Fentanyl showed a better analgesic effect in moderate to severe pain
Subject(s)
Humans , Infant, Newborn , Pain, Postoperative , Infant, Newborn , Analgesics , Analgesics, Opioid , AcetaminophenABSTRACT
Aims: To assess pharmacokinetic (PK) bioequivalence between a newly developed formulation, rapid-relese paracetamol plus sodium bicarbonate and caffeine (RAPC), containing 500 mg paracetamol + 65 mg caffeine + 325 mg sodium bicarbonate), and the currently marketed Panadol® Extra product in both the fasted and semi-fed states. Study Design: A single center, randomized, open label, four-way crossover, PK study. Place and Duration of Study: MDS Pharma Services (Now Celerion), 2420, W. Baseline Road, Tempe, AZ 85283, between July 17, 2009 to August 10, 2009. Methodology: We included 30 healthy volunteers (20 males, 10 females; age range 18- 55 years). The characterized PK parameters included total and partial area under the concentration time curve (AUC0-30min, AUC0-60min, AUC0-t/AUC0-∞), time to reach peak drug plasma concentration/therapeutic level (Tmax/Tc≥4ug/ml), and maximum measured plasma concentration (Cmax). The safety of the study treatments was also assessed. Results: In both fasted and semi-fed states, the exposure to paracetamol and caffeine for new RAPC formulation was bioequivalent to Panadol® Extra for AUC0-10 hrs, AUC0-∞ and Cmax with 90% confidence intervals (CIs), all being within the range 0.80 to 1.25, except for a higher paracetamol Cmax for RAPC in fasted state. RAPC exhibited significantly greater early absorption for both paracetamol (≥1.8-fold greater) and caffeine (≥1.3-fold greater) as determined by AUC0-30min and AUC0-60min, as well as significantly faster Tmax for both paracetamol (about 30 minutes faster) and caffeine (≥15 minutes faster) compared to currently marketed Panadol® Extra in both fasted and semi-fed states. The time to reach the therapeutic paracetamol plasma concentration (Tc≥4μg/ml) was about 12 and 33 minutes faster in fasted and semi-fed states respectively. The new formulation was safe and well tolerated. Conclusion: The newly developed RAPC formulation was found to be bioequivalent to Panadol® Extra caplets, and showed significantly faster absorption in both fasted and semi-fed states.