Efectividad analgésica del clonixinato de lisina asociado con el paracetamol en el tratamiento posoperatorio de exodoncias / Analgesic Effectiveness of Lysine Clonixinate Associated with Paracetamol in the Postoperative Treatment of Exodontias / Efetividade analgésica do clonixinato de lisina associado ao paracetamol no tratamento pós-operatório de exodontias

Resumen Introducción : el uso de terapias analgésicas para controlar el dolor postexodoncia es muy variado y depende muchos factores. El objetivo de este estudio fue comparar la efectividad analgésica del paracetamol asociado con el clonixinato de lisina y compararlo con monoterapias de paracetamol e ibuprofeno en el tratamiento posoperatorio de exodoncias. Materiales y métodos : la muestra estuvo conformada por 39 pacientes distribuidos aleatoriamente en tres grupos. El dolor posoperatorio se midió utilizando la Escala Visual Análoga (EVA) 1 h, 8 h y 24 h postexodoncia. El análisis estadístico de la evolución de las tres terapias, se realizó empleando el test t de Student, ANOVA y test de Tuckey, con un nivel de significancia de p < 0.05. Resultados : los valores obtenidos demostraron que la combinación analgésica de paracetamol asociado con el clonixinato de lisina fue más efectiva 1 h y 8 h después. A las 24 h no existieron diferencias en los tres grupos de estudio. Conclusión : la analgesia de la terapia combinada de Paracetamol asociada con el Clonixinato de lisina es superior a la producida por la dosis estándar de Ibuprofeno y Paracetamol en el tratamiento del dolor posoperatorio de exodoncias simples.

Abstract Introduction : The use of analgesic therapies to control post-exodontia pain is very varied and depends on many factors. The study had two aims: to compare the analgesic effectiveness of paracetamol associated with lysine clonixinate and to compare it with monotherapies of paracetamol and ibuprofen in exodontias' postoperative treatment. Materials and methods : The sample consisted of 39 patients randomized into three groups. The postoperative pain was measured using the Visual Analogue Scale (VAS), at 1h, 8h, and 24h after exodontia. Statistical analysis of the evolution of the three therapies was performed using Student's t-test, ANOVA and Tuckey's test, with a level of significance of p <0.05. Results : The values obtained showed that the analgesic combination of paracetamol associated with clonixinate of lysine was more effective at 1h and 8h. At 24h, there were no differences in the three study groups. Conclusion : The analgesia of the combined therapy of paracetamol associated with clonixinate of lysine is superior to that produced by the standard dose of ibuprofen and paracetamol in the treatment of post-operation pain of simple extractions.

Resumo Introdução : o uso de terapias analgésicas para controlar a dor pós-exodontia é muito variada e depende de muitos fatores. O objetivo deste estudo foi comparar a efetividade analgésica do paracetamol associado ao clonixinato de lisina e compará-lo com monoterapias de paracetamol e ibuprofeno no tratamento pós-operatório de exodontias. Materiais e métodos : a amostra esteve conformada por 39 pacientes distribuídos aleatoriamente em três grupos. A dor pós-operatória mediu-se utilizando a Escala Visual Análoga (EVA) às 1 h, 8 h e 24 h pós-exodontia. A análise estatística da evolução das três terapias, se realizaram empregando o teste t de Student, ANOVA e teste de Tuckey, com um nível de significancia de p<0.05. Resultados : os valores obtidos demostraram que a combinação analgésica de paracetamol associado a clonixinato de lisina, foi mais efetiva às 1 h e 8 h. Às 24 h, não existiram diferenças nos três grupos de estudo. Conclusão : a analgesia da terapia combinada de Paracetamol associado a Clonixinato de lisina, é superior à produzida pela dose standard de Ibuprofeno e Paracetamol no tratamento da dor pós-operatória de exodontias simples.

Analgesic efficacy of lysine clonixinate plus tramadol versus tramadol in multiple doses following impacted third molar surgery.

This study compared the analgesic and anti-inflammatory efficacy, trismus control, and tolerability of the combination of lysine clonixinate and tramadol (LCT) versus tramadol (T) alone after surgical removal of impacted mandibular third molars. This study was a double-blind, randomized clinical trial, including two study groups of 20 patients each, who exhibited acute pain subsequent to surgical extraction of two mandibular third molars. Pain intensity was quantified over a 96-h period using a visual analogue scale and a 5-point verbal rating scale. Secondary indicators of analgesic and anti-inflammatory efficacy, trismus control, and tolerability were determined. Patients administered LCT exhibited better therapeutic effects that those administered T. Fifty percent of patients in the LCT group rated this therapy as 'excellent analgesia' compared with only 10% in the T group. The onset of the analgesic effect of LCT was significantly faster, without any therapeutic failures. There were no significant differences between the groups with regard to anti-inflammatory effect or trismus. The results of this study suggest that the postsurgical analgesic efficacy of LCT in combination (LC 125 mg + T 25 mg) is superior to that obtained with T alone, administered at the standard dose of 50 mg, for up to 96 h after the extraction of both impacted mandibular third molars.

Efectividad de la profilaxis analgésica con clonixinato de lisina en exodoncias: ensayo clínico aleatorio / Effectiveness of preemptive lysine clonixinate in tooth extraction: a randomized controlled trial

Objetivo: Evaluar la efectividad de la profilaxis analgésica con dosis únicas de clonixinato de lisina (CL 125mg) en pacientes sometidos a extracciones dentales. Metodología: Ensayo clínico aleatorio, doble enmascaramiento placebo-controlado. Participaron pacientes ASA I y II con indicación de exodoncia dental de servicios públicos en la ciudad de Valdivia-Chile en el mes de octubre del 2012. Se asignó de manera aleatoria dos grupos: un grupo tratamiento quienes recibieron una dosis de 25mg de CL 15 minutos antes de la cirugía; y un grupo control quien recibió un placebo. A ambos grupos se indicó CL como analgésico de rescate. Mediante un cuestionario, los pacientes registraron el grado de dolor a través de una Escala Visual Análoga (EVA) durante primer día en las 7 primeras horas, después de 24 y a las 48 horas posterior a la cirugía. Además, se registró número de cápsulas de CL consumidos como rescate durante 3 días posteriores a la intervención. Se comparó el efecto analgésico observado (EVA) y el número de consumo de analgésicos adicionales entre ambos grupos mediante t-test (p<0,05). Resultados: Cincuenta y cuatro pacientes fueron intervenidos. No se encontró diferencia estadísticamente significativa entre las puntuaciones de dolor entre ambos grupos. Los pacientes con profilaxis de CL informaron similar consumo de números de cápsulas de rescate que el grupo control. Conclusión: La profilaxis analgésica con CL no demostró ser más efectiva en la reducción del dolor luego de extracciones dentales en comparación al uso de placebo y dosis postquirúrgicas.

Aim: To evaluate the effectiveness of prophylaxis with single-dose analgesic clonixinate lysine (CL 125 mg) in patients undergoing tooth extraction. Methods: A double-blind randomized placebo-controlled trial. Were included in the study patients ASA I and II with dental extraction indication in the city of Valdivia, Chile in October 2012. Were randomly assigned in two groups: the treatment group received a doses of 125mg of CL fifteen minutes before the surgery, and a control group who received placebo. Both groups used a CL as a rescue analgesic. Using a survey, patients reported the degree of pain via a visual analog scale (VAS) during the first day, at 24 and 48 hours after surgery. In addition, registered the number of CL capsules consumed as a ransom for 3 days after the surgery. We compared the analgesic effect observed in (VAS) and the number of additional analgesic consumption between the two groups using t-test (p <0,05). Results: Fifty-four patients were operated and there was no statistically significant difference between the pain scores between the two groups. Premedication patients reported the use of equal number of rescue capsules comparing with the control group. Conclusion: CL analgesic prophylaxis proved no more effective in reducing pain after tooth extraction when comparing to the use of placebo in a postoperative doses.

Tratamento da dor associada à osteoartrose de joelho em idosos: um ensaio clínico aleatório e duplamente encoberto com o clonixinato de lisina / Treatment of pain associated to knee osteoarthrosis in elderly people: a randomized double-blind clinical trial with lysine clonixinate

JUSTIFICATIVA E OBJETIVOS: A osteoartrose (OA) é a artropatia mais comum e uma das principais causas de dor crônica na população idosa, podendo levar a grande incapacidade funcional nestes indivíduos. Objetivando o tratamentoda dor em idosos com OA de joelho utilizou-se o clonixinato de lisina (CL) e avaliou-se a sua efetividade.MÉTODO: Estudo clínico e duplamente encoberto,aleatório e placebo controlado com 109 idosos com dor associada à OA de joelho. Os participantes foram divididos em dois grupos: Grupo CL e P (placebo) que receberam comprimidos para uso três vezes ao dia por 30 dias.Realizadas avaliações iniciais, após 15 dias e ao final doestudo, quanto à intensidade de dor em repouso, ao movimento inicial, à deambulação e à compressão articular; necessidade de analgesia complementar, rigidez matinal; incapacidade funcional associada à dor, aderência, tolerabilidade e avaliação global do tratamento.RESULTADOS: O CL reduziu significantemente a dor ao início do movimento e à deambulação já nos primeiros 15 dias, redução de 30% da dor protocinética e de 31,6% à deambulação, mas os melhores resultados ocorreram com 30 dias, quando as reduções foram de 42,3% e 45,5%, protocinética e à deambulação, respectivamente. A analgesia complementar foi significantemente menor com o CL: 2,6% e 9,5%, grupos CL e P, respectivamente. Não ocorreram diferenças entre os grupos para rigidez matinal e incapacidade funcional. Houve grande aderência e tolerabilidade. A avaliação global foi favorável para o CL,sendo excelente ou boa em 50%.CONCLUSÃO: O clonixinato de lisina foi efetivo no tratamento da dor associada à osteoartrite de joelho em idosos.

BACKGROUND AND OBJECTIVES: Osteoarthrosis (OA) is the most common arthropathy and one of the major causes of chronic pain in elderly population, which may lead to major functional incapacity of these individuals.Aiming at treating pain of elderly patients with knee OA,we have used lysine clonixinate (LC) and have evaluated its effectiveness. METHOD: Randomized, double-blind, placebo-controlledclinical trial with 109 elderly patients with painassociated to knee OA. Participants were distributed in two groups: Group LC and Group P (placebo), who received tablets to be used three times a day for 30 days.Evaluations were performed initially, 15 days after andat study completion, as to pain intensity at rest, at initial movement, walking and joint compression, and the needfor additional analgesia, morning stiffness; pain-related functional incapacity, adherence, tolerability and global treatment valuation.RESULTS: LC has signifi cantly decreased pain at initialmovement and walking already in the first 15 days, with 30% decrease in protokinetic pain and 31.6% in walking, but best results were seen after 30 days, when reductions were 42.3% and 45.5%, respectively. Additional analgesia was significantly lower with LC: 2.6% and 9.5% for groups LC and P, respectively. There were no differences between groups in morning stiffness and functional incapacity.There has been major adherence and tolerability.Global evaluation was favorable to LC, being excellent orgood for 50% of patients.CONCLUSION: Lysine clonixinate was effective to trea tpain associated to knee osteoarthritis in elderly people.

Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study / Clonixinato de lisina versus dipirona (metamizol) para o tratamento agudo de uma crise intensa de enxaqueca: estudo monocego e randomizado

BACKGROUND AND OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. METHOD: Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Society (IHS) (2004) were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM) was available after 2 hours and its use compared between groups. RESULTS: All patients completed the study. At 30 minutes, 0 percent of the dipyrone group 13 percent of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13 percent) and 5 (33 percent) patients from the dipyrone group and 11 (73 percent) and 13 (86.7 percent) patients from the LC group were pain free (p<0.001). At 60 minutes, significantly more patients from the LC group were nausea-free (p<0.001). Regarding photophobia, there were no differences between groups at 60 minutes (p=0.11). The use of RM at 2 hours did not differ among groups (p=0.50). Pain in the site of the injection was reported by more patients of the LC group compared to the dipyrone group (p<0.0001). CONCLUSION: LC is significantly superior to dipyrone in treating severe migraine attacks. LC promotes significantly more burning at the site of the injection.

CONTEXTO E OBJETIVO: Antiinflamatórios não esteroidais (AINE) são eficazes no tratamento de crises de enxaqueca. O objetivo deste estudo foi comparar a eficácia e a tolerabilidade das apresentações injetáveis do clonixinato de lisina (CL) e da dipirona no tratamento de crises intensas de enxaqueca. MÉTODO: Trinta pacientes (28 mulheres, 2 homens), com idades entre 18 e 48 anos e enxaqueca de acordo com a Classificação Internacional de Cefaléias (2004) foram estudados. Os pacientes foram randomizados em 2 grupos ao se apresentarem em uma unidade de emergência, com uma crise intensa de enxaqueca. O desenho do estudo foi monocego. A intensidade da cefaléia, a presença de náusea e fotofobia e os efeitos colaterais foram avaliados e comparados na administração das drogas e após 30, 60 e 90 minutos. Indometacina retal foi disponibilizada como droga de resgate (DR) e seu uso comparado entre os grupos. RESULTADOS: Todos os pacientes completaram o estudo. Após 30 minutos, 0 por cento do grupo da dipirona e 13 por cento do CL encontravam-se sem cefaléia (p=0,46). Após 60 e 90 minutos, 2 (13 por cento) e 5 (33 por cento) do grupo da dipirona e 11 (73 por cento) e 13 (86,7 por cento) do grupo do CL encontravam-se sem cefaléia (p<0,001). Após 60 minutos, o CL foi mais eficaz que a dipirona em eliminar a náusea (p<0,001), mas não houve diferença quanto à melhora da fotofobia entre os grupos (p=0,11). Não houve diferenças entre os grupos que utilizaram DR (p=0,50). Dor no local da injeção foi apresentada por mais pacientes que usaram CL comparados aos da dipirona (p<0,001). CONCLUSÃO: O CL é significativamente superior a dipirona no tratamento de uma crise intensa de enxaqueca, mas resulta em mais queimação no local da injeção.

Intravenous lysine clonixinate for the acute treatment of severe migraine attacks: a double-blind, randomized, placebo-controlled study.

BACKGROUND: Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been shown to be effective in the treatment of migraine. However, few commercially available NSAIDs can be administered IV. Lysine clonixinate (LC), an NSAID derived from nicotinic acid, has been proved effective in various algesic syndromes (eg, renal colic, muscular pain, nerve compression, odontalgia). The oral formulation of LC has been shown to be effective in the treatment of migraine of moderate severity. OBJECTIVE: The aim of this study was to assess the efficacy and tolerability of the IV formulation of LC in the treatment of severe migraine. METHODS: This double-blind, randomized, placebo-controlled, prospective study enrolled patients with severe migraine (without aura) as defined by the criteria of the International Headache Society. When patients presented to a neurology hospital with an outpatient headache unit (Instituto de Neurologia Deolindo Couto, Rio de Janeiro, Brazil) with a severe migraine attack that had lasted <4 hours, they were randomized to 1 of 2 groups (IV placebo [25 mL of 0.9% saline] or IV LC [21 mL of 0.9% saline plus 4 mL of LC 200 mg]). Headache intensity and adverse effects (AEs) were assessed before (0 minute) and 30, 60, and 90 minutes after study drug administration. Rescue medication was available 2 hours after study drug administration, and its use was compared between groups. RESULTS: Thirty-two patients (23 women, 9 men; mean [SD] age, 32 [2] years; range, 18-58 years) entered the study. Twenty-nine patients (21 women, 8 men; mean [SD] age, 32 [2] years; range, 18-56 years) completed the study. Three patients (all in the placebo group) did not complete the study (1 patient was unable to rate the pain severity after drug administration and 2 patients refused IV drug administration). Among study completers, 17 patients received LC and 12 placebo. At 30 minutes, 1 patient (8.3%) in the placebo group and 5 patients (29.4%) in the LC group were pain free; the between-group difference was not statistically significant. At 60 and 90 minutes, respectively, 3 (25.0%) and 5 (41.7%) patients in the placebo group and 12 (70.6%) and 14 (82.4%) patients in the LC group were pain free (P = 0.021 and P = 0.028 between groups at 60 and 90 minutes, respectively). Six patients (50.0%) in the placebo group and 1 patient (5.9%) in the LC group required rescue medication at 2 hours (P = 0.010 between groups). Three patients (25.0%) in the placebo group experienced AEs, including vomiting, dizziness, and malaise (1 patient [8.3%] each); 11 patients (64.7%) in the LC group experienced 1 AE, including burning pain at the injection site (5 patients [29.4%]), heartburn (4 patients [23.5%]), and dizziness and malaise (1 patient [5.9%] each) (P = 0.025). CONCLUSIONS: NSAIDs administered by the IV route cannot be used routinely in an outpatient environment, although an attempt to improve drugs in this class is clearly justified. This study demonstrated that IV LC was effective and well tolerated in the treatment of severe migraine attacks. This finding differs from results with the oral formulation, which is effective only in migraine of moderate severity.