Estabilidad de parecoxib en dilución con otros fármacos y administración en perfusión continua IV para el control del dolor postoperatorio

2007 
espanolObjetivo: Evaluar la estabilidad de parecoxib en un sistema de infusion continua elastomerica portatil IV para 24 horas, en dilucion con opiaceos (cloruro morfico, meperidina o tramadol), antiemeticos y suero fisiologico, durante las 24 horas del postoperatorio; asi como, comprobar el resultado analgesico, la aparicion de efectos secundarios y el grado de satisfaccion de pacientes intervenidos de cirugia mayor susceptibles de tratamiento con dichos farmacos. Material y Metodos: El infusor es un dispositivo desechable y ligero con un deposito elastomerico para administrar medicacion. Se realizaron varias pruebas mezclando parecoxib, opiaceos, antiemeticos y suero fisiologico y se observo su estabilidad durante 24 horas. Procedimos a observar la mezcla en repetidas ocasiones y la dilucion siempre permanecio estable, clara, sin particulas y transparente; por lo que se decidio utilizar dicha mezcla en el infusor IV para el tratamiento del dolor postoperatorio, siempre bajo la supervision de un anestesiologo. Se estudiaron un total de 118 pacientes, 46 mujeres (39%) y 72 hombres (61%), ASA I-IV, edad media 59,75 +/- 14,25 (18-89), 92 (78%) fueron intervenidos de cirugia general y 26 (22%) de urologia. El llenado del infusor segun ASA, edad y tipo de intervencion del paciente, se realizo con: parecoxib 80 mg + metoclopramida Cl H 20 o 30 mg + suero fisiologico en los 118 pacientes, se anadio cloruro morfico en 65 pacientes, meperidina en 30 y tramadol en 23, a administrar en 24 horas tras la intervencion quirurgica. Se valoro la intensidad del dolor segun EAV a la llegada a la Sala de Despertar y a las 24 horas, resultado analgesico, efectos secundarios y grado de satisfaccion. Resultados: El resultado analgesico fue muy bueno en 60 pacientes (50,85%); bueno en 40 (33,90%); regular en 12 (10,17%) y suspendido el tratamiento en 6 (5%) por efectos secundarios. Los efectos secundarios aparecieron en 30 casos (25%): 4 con sudoracion (3%), 1 con desorientacion (0,8%) y 7 con somnolencia y mareo (6%) 3 de ellos con interrupcion del tratamiento. En cuanto a las nauseas y/o vomitos: 18 pacientes necesitaron rescate antiemetico, y en 3, hubo que suspender el tratamiento. El grado de satisfaccion del paciente fue: muy satisfactorio en 56 pacientes (47,5%); satisfactorio en 46 (39%), deficiente en 10 (8,5%) y suspendido el tratamiento en 6 (5%) por efectos secundarios. Conclusiones: La posibilidad de utilizar parecoxib solo o unido a otros farmacos en perfusion continua IV para el tratamiento del dolor agudo postoperatorio, es una opcion a considerar. EnglishObjective: To evaluate the stability of parecoxib in a portable elasto-meric pump system for IV infusion in dilution with opioids (morphine chloride, pethidine or tramadol), antiemetics and saline solution during 24 hours in the postoperative period; as well as to verify the analgesic result, the incidence of side effects and the degree of satisfaction in patients undergoing major surgery that were eligible for treatment with these drugs. Material and Methods: The infuser pump is a light disposable device with an elas-tomeric deposit to administer the medication. Several tests combining parecoxib, opioids, antiemetics and saline solution were carried out and its stability was demonstrated during 24 hours. The mixture was then observed in several occasions and was shown that the dilution always remained stable, clear, with no particles and transparent; therefore it was decided to use that combination in the IV infuser for the treatment of postoperative pain, always under the anaesthesiologist supervision. A total of 118 patients were studied, 46 women (39%) and 72 men studied (61%), ASA ITV, mean age 59.75 +/- 14.25 (18-89); 92 (78%) underwent general surgery procedures and 26 (22%) urologic ones. The filling of infuser according to ASA, age and type of surgery of the patient, was made with: parecoxib 80 mg + metoclopramide CL H 20 or 30 mg + saline solution for the 118 patients, morphine chloride was added in 65 patients, petidine in 30 and tramadol in 23, during 24 hours after surgery. Pain was assessed using a VAS in both at arrival in the PACU and 24 hours after the surgical procedures. Analgesic outcome, side effects and degree of satisfaction were re-corded. Results: The analgesic outcome was very good in 60 patients (50.85%); good in 40 (33.90%); regular in 12 (10.17%) and the treatment was interrupted 6 (5%) due to side effects. Side effects were present in 30 (25%) cases: 4 with perspiration (3%), 1 with disorientation (0.8%) and 7 with somnolence and dizziness (6%) 3 of them with interruption of the treatment. For nausea and vomiting, 18 patients needed antiemetics res-cue, and in 3 cases it was necessary to suspend the treatment. The degree of satisfaction reported by patients was: very satisfactory in 56 patients (47.5%); satisfactory in 46 (39%), inadequate in 10 (8.5%) and the treatment was suspended in 6 (5%) due to side effects. Conclusions: The possibility of using parecoxib alone or in combination with other drugs in continuous IV perfusion for acute postoperative pain is an important option to be considered.
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