ABSTRACT
Resumen Antecedentes: cada vez es más frecuente el uso de sedación-analgesia para procedimientos dolorosos en áreas de urgencias pediátricas, pero esta conducta todavía no es generalizada. No existe consenso sobre la asociación más eficaz y segura de fármacos a utilizar en estos procedimientos. Objetivo: evaluar eficacia y seguridad de la sedación-analgesia para procedimientos ortopédicos dolorosos en niños, efectuados en un área de urgencia pediátrica y comparar tres diferentes regímenes terapéuticos. Material y métodos: ensayo clínico prospectivo, aleatorizado, con pacientes ambulatorios en un Departamento de Urgencia Pediátrica, en el período comprendido desde 11 de diciembre de 2001 al 4 de enero de 2003. Se compararon tres protocolos: midazolam/fentanilo (M-F), lidocaína/propofol/fentanilo (L-P-F) y atropina/midazolam/ketamina (A-M-K). La eficacia se evaluó a través del grado de analgesia y sedación intraprocedimiento, necesidad de reiterar dosis de fármacos, grado de dolor postprocedimiento, grado de reducción del dolor y amnesia del procedimiento. La seguridad se evaluó por los siguientes efectos adversos: disminución de SatO2, apnea, bradicardia, hipotensión arterial y alucinaciones durante el procedimiento, y cambios de conducta posteriores. Resultados: fueron incluidos 61 niños: 20 (M-F), 21 (L-P-F), 20 (A-M-K), que resultaron comparables en edad, sexo, peso, tipo de lesión y grado de dolor previo. No hubo diferencias en el grado de analgesia y sedación entre las tres cohortes comparadas, obteniéndose un nivel muy satisfactorio con los tres protocolos, con 98,4% de amnesia del procedimiento. Se produjo disminución de la SatO2 en el 16,4% de los casos, predominando en el grupo L-P-F. El grupo A-M-K registró el menor número de efectos adversos (p: 0,02 - riesgo relativo de 0,19; rango 0,03 a 1,34; intervalo de confianza de 95%). Éstos se solucionaron con medidas de soporte vital básico. Conclusiones: los tres protocolos mostraron un alto nivel de eficacia y seguridad y no se observaron diferencias significativas entre ellos.
Summary Introduction: the use of analgesia and sedation in pain treatment is increasing in the Pediatric Emergency Department, however it has not been overexposed yet. There is no agreement about which drug association is more effective and safer to use. Objective: to evaluate safeness and efficacy of three different therapies for painful orthopedic procedures performed in children at the emergency department. Methods: a prospective, randomized clinical trial was done with patients between December 2001 and January 2003 at the emergency department.Three different therapies were compared: midazolam/fentanyl (M-F), lydocaine/propofol//fentanyl (L-P-F) and atropine/midazolam/ketamine (A-M-K). The efficacy was assessed by comparing sedation-analgesia degrees during the procedure, the need to repeat doses, pain scores post-procedure, pain reduction scores and amnesia of the procedure. Safety was assessed by considering the following adverse effects: SatO2 decrease, apnea, bradycardia, arterial hypotension, intra-procedure hallucinations and behavioral changes after procedure. Results: sixty-one patients were included in the study and randomly distributed into three groups: 20 M-F, 20 A-M-K and 21 in L-P-F. Age, gender and weight distribution along with the kind of injury and pain scores done previously to the procedure were comparable. High sedation-analgesia scores were obtained with all the protocols with no differences found between them. 98,4% of the patients did not recall the procedure. SatO2 decrease was observed in 16,4% of the cases prevailling in the L-P-F group. The A-M-K group had the lowest number of adverse effects (p: 0,02-RR 0,19; [0,03 to 1,34]; IC 95%). In all cases adverse effects were overcome with basic support measures. Conclusions: the three protocols were highly effective and safe. No difference was observed between them.
ABSTRACT
Este trabalho prospectivo, duplo-cego randomizado, avaliou o efeito da analgesia preemptiva do cetoprofeno e do parecoxibe. Sessenta pacientes foram submetidos à cirurgia para remoção de terceiros molares inferiores bilaterais inclusos, sendo operado um lado de cada vez. O paciente foi seu próprio controle. Os pacientes foram separados em dois grupos de 30 pacientes. No grupo parecoxibe, na primeira operação foi usado o parecoxibe ou placebo, endovenoso, 30 minutos antes da cirurgia e imediatamente após a operação foi feita a administração do placebo ou parecoxibe, garantindo ao paciente receber parecoxibe antes ou após a operação. O lado oposto foi operado após duas semanas da primeira cirurgia e o paciente que havia recebido parecoxibe antes e placebo depois da operação recebeu placebo antes e parecoxibe depois da operação e o que havia recebido placebo antes e parecoxibe depois recebeu parecoxibe antes e placebo depois. Nos 30 pacientes do grupo cetoprofeno, o modelo foi o mesmo, substituindo-se apenas o parecoxibe pelo cetoprofeno. O paciente pôde utilizar como medicação resgate a dipirona, sempre que necessário para controlar a dor pós-operatória. Após a operação foi fornecido para todos os pacientes um questionário, contendo a escala analógica visual (EAV), a escala descritiva de dor (EDD) e uma tabela para informar o consumo de medicação resgate. Foi avaliada a dor pós-operatória por meio da EAV, da EDD e pelo consumo de medicação resgate. Não houve diferença estatisticamente relevante quanto a intensidade da dor com o uso do parecoxibe ou do cetoprofeno antes ou depois do procedimento cirúrgico. Ao comparar a analgesia proporcionada pelo cetoprofeno e pelo parecoxibe os resultados mostraram que o parecoxibe administrado antes do procedimento cirúrgico foi mais eficaz do que o cetoprofeno no controle da dor na quarta hora do pós-operatório (p=0,041), mas foi menos eficaz após 24h (p=0,003). Quando se comparou a analgesia proporcionada por esses...
This is a prospective, double-blind randomized, cross over experiment, to evaluate the effect of the preemptive analgesia of ketoprofen and parecoxib. Sixity patients who had gone though surgery for removal of the impacted mandibular bilateral third molar teeth, having one side operated each time, were evaluated. The patients were separated in groups of 30, in the parecoxib group (P). On the first operation parecoxib or placebo were used 30 minutes before the surgery. Immediately after the operation, placebo or parecoxib were administred, so that the patient who had received parecoxib before the operation or after it. The opposite side was operated two weeks after the first surgery and the patients who received parecoxib before and placebo after operation received placebo before and parecoxib after operation and patients who received placebo before and parecoxib after received parecoxib before and placebo after, under the same method. In the group C (n= 30), the model was the same, using ketoprofen instead parecoxib. The patient could use dipyrone as rescue medication, in the event of postoperative pain. A questionnaire was provided to the patient after each surgery, containing a visual analogic scale, a descriptive pain scale and a table to inform the consum of rescue medication. The postoperative pain was evaluated by visual analogic scale, descriptive pain scale and rescue medicine consum. There was no statistically relevant difference as pain intensity with use of parecoxib or ketoprofen before or after the surgical procedure. Comparing ketoprofen analgesia against parecoxib analgesial, the results shown that the administration of parecoxib before the surgical procedure had a major efficacy than ketoprofen in pain control by the fourth hour post operatory (p=0,041), but was less efficient after 24 hours (p=0,003). When comparing the analgesic effect of both drugs after the operation, parecoxib was more effective than ketoprofen six and eight hours after...