Comparison of tramadol and lornoxicam in intravenous regional anesthesia: a randomized controlled trial / Comparação de tramadol e lornoxicam em anestesia regional por via intravenosa, um estudo randomizado e controlado

BACKGROUND AND OBJECTIVES: Tourniquet pain is one of the major obstacles for intravenous regional anesthesia. We aimed to compare tramadol and lornoxicam used in intravenous regional anesthesia as regards their effects on the quality of anesthesia, tourniquet pain and postoperative pain as well. METHODS: After the ethics committee approval 51 patients of ASA physical status I-II aged 18-65 years were enrolled. The patients were divided into three groups. Group P (n = 17) received 3 mg/kg 0.5% prilocaine; group PT (n = 17) 3 mg/kg 0.5% prilocaine + 2 mL (100 mg) tramadol and group PL (n = 17) 3 mg/kg 0.5% prilocaine + 2 mL (8 mg) lornoxicam for intravenous regional anesthesia. Sensory and motor block onset and recovery times were noted, as well as tourniquet pains and postoperative analgesic consumptions. RESULTS: Sensory block onset times in the groups PT and PL were shorter, whereas the corresponding recovery times were longer than those in the group P. Motor block onset times in the groups PT and PL were shorter than that in the group P, whereas recovery time in the group PL was longer than those in the groups P and PT. Tourniquet pain onset time was shortest in the group P and longest in the group PL. There was no difference regarding tourniquet pain among the groups. Group PL displayed the lowest analgesic consumption postoperatively. CONCLUSION: Adding tramadol and lornoxicam to prilocaine for intravenous regional anesthesia produces favorable effects on sensory and motor blockade. Postoperative analgesic consumption can be decreased by adding tramadol and lornoxicam to prilocaine in intravenous regional anesthesia.

JUSTIFICATIVA E OBJETIVOS: A dor relacionada ao torniquete é um dos maiores obstáculos para a anestesia regional intravenosa (ARIV). Nosso objetivo foi comparar tramadol e lornoxicam usados em ARIV em relação aos seus efeitos sobre a qualidade da anestesia, dor relacionada ao torniquete e dor no pós-operatório. MÉTODOS: Após a aprovação do Comitê de Ética, 51 pacientes com estado físico ASA I-II entre 18-65 anos foram inscritos. Os pacientes foram divididos em três grupos. Grupo P (n = 17) recebeu 3 mg/kg de prilocaína a 0,5%; Grupo PT (n = 17) 3 mg/kg de prilocaína a 0,5% + 2 mL (100 mg) de tramadol e Grupo PL (n = 17) de 3 mg/kg de prilocaína a 0,5% + 2 mL (8 mg) de lornoxicam para ARIV. O início do bloqueio sensorial e motor e os tempos de recuperação foram registrados, bem como a dor relacionada ao torniquete e o consumo de analgésico no pós-operatório. RESULTADOS: Os tempos de início do bloqueio sensorial foram mais curtos nos grupos PT e PL, enquanto que os tempos de recuperação correspondentes foram mais longos do que os do Grupo P. Os tempos de início do bloqueio motor nos grupos PT e PL foram menores do que no Grupo P, enquanto que o tempo de recuperação do grupo PL foi maior do que os dos grupos P e PT. O tempo para início da dor relacionada ao torniquete foi menor no Grupo P e maior no Grupo PL. Não houve diferença em relação à dor relacionada ao torniquete entre os grupos. O Grupo PL apresentou o menor consumo de analgésicos no pós-operatório. CONCLUSÃO: A adição de tramadol e lornoxicam à prilocaína para ARIV produz efeitos favoráveis sobre o bloqueio sensorial e motor. O consumo de analgésicos no pós-operatório pode ser reduzido com a adição de tramadol e lornoxicam à prilocaína em ARIV.

Effective method for the detection of piroxicam in human plasma using HPLC

Abstract Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used by the general population to alleviate inflammation and pain after oral surgeries. Piroxicam is among the most commonly used NSAIDs and excels in controlling pain, swelling, trismus and other common symptoms of inflammation. This study aimed to evaluate different concentrations of piroxicam and its major metabolite, 5'-hydroxypiroxicam, in human plasma samples over time using high performance liquid chromatography (HPLC) after liquid-liquid extraction. Briefly, 10 volunteers participated in this study after approval by the Ethics Committee of Bauru School of Dentistry, Universidade de São Paulo - USP, Brazil. Volunteers received a single dose oral of piroxicam (20 mg) and had blood collected at various times following an established protocol. The methodology of liquid-liquid extraction was effective for determining concentrations of piroxicam in plasma using HPLC in 10 out of 10 volunteers while 5'-hydroxypiroxicam was only detected in 2 out of 10 volunteers.

Comparison of the effectivity of oral and intra-articular administration of tenoxicam in patients with knee osteoarthritis / Comparação da eficácia de tenoxicam administrado por via oral e intra-articular a pacientes com osteoartrite de joelhos

ABSTRACTBACKGROUND AND OBJECTIVES:Tenoxicam is widely used in osteoarthritis treatment and we aimedto compare the effectivity of oral and intra-articular administration of tenoxicam in osteoarthri-tis treatment.METHODS: This study was performed between 2011 and 2012 by retrospectively analyzing andcomparing the findings of 60 patients who were clinically and radiologically diagnosed with kneedegenerative osteoarthritis in Bünyan state hospital pain policlinic. 60 patients included in thestudy were divided into two groups. The first group (tenoxicam IA, n = 30) included patientfindings of those subjected to intra-articular injection of 20 mg tenoxicam to the knee oncea week for three weeks and the second group (oral tenoxicam, n = 30) included patients whowere administered 20 mg oral tenoxicam once a day for three weeks. All patients were clini-cally evaluated pre-treatment and in the 1st week, 1st month and 3rd month post-treatmentaccording to specified criteria.RESULTS AND CONCLUSIONS: Twenty two of 60 patients included in the study were male and 38were female. In both groups significant improvements were detected in all of the observedparameters: visual analog scale, Western Ontario McMaster Osteoarthritis Index (pain, physicalactivity, knee stiffness) and Lequesne index scores and in the evaluations performed in 1st week,1st month and 3rd month with respect to pre-treatment values. Besides, a better complianceto treatment and gastrointestinal system tolerability in tenoxicam IA group was also observed.Intra-articular tenoxicam administration could be thought as an alternative treatment methodin patients with knee osteoarthritis who cannot use oral tenoxicam especially due to systemicgastrointestinal system side effects and those who have difficulties in adapting to treatment.

RESUMOJUSTIFICATIVA E OBJETIVOS: Tenoxicam é amplamente usado no tratamento da osteoartrite (OA)e o nosso objetivo foi comparar a eficácia de tenoxicam administrado por via oral (VO) e intra-articular (IA) no tratamento da OA.MÉTODOS: Este estudo foi conduzido entre 2011 e 2012 por meio de análise retrospectiva ecomparação dos resultados de 60 pacientes que foram clínica e radiologicamente diagnosticadoscom OA degenerativa de joelhos na Policlínica de Tratamento da Dor do Hospital Estadual deBünyan. Os 60 pacientes incluídos no estudo foram alocados em dois grupos. O primeiro grupo(tenoxicam IA, n = 30) incluiu resultados de pacientes submetidos à injeção nos joelhos porvia IA de 20 mg de tenoxicam uma vez por semana durante três semanas e o segundo grupo(tenoxicam VO, n = 30) incluiu pacientes que receberam 20 mg de tenoxicam por VO uma vezpor dia durante três semanas. Todos os pacientes foram avaliados clinicamente na fase basalpré-tratamento e em uma semana, um mês e três meses pós-tratamento, de acordo com oscritérios especificados.RESULTADOS E CONCLUSÕES: Dos 60 pacientes, 22 eram do sexo masculino e 38 do sexo feminino.Em ambos os grupos, melhorias significativas foram detectadas em todos os parâmetros da escalavisual analógica, do índice Western Ontario and MacMaster (Womac --- dor, atividade física erigidez dos joelhos) e do índice de Lequesne nas avaliações feitas em uma semana, um mês etrês meses e comparadas aos valores basais. Além disso, uma melhor adesão ao tratamento etolerabilidade ao sistema gastrointestinal no grupo tenoxicam IA também foram observadas. Aadministração de tenoxicam IA pode ser considerada como um método opcional de tratamentoem pacientes com OA de joelhos que não podem usar tenoxicam por VO, especialmente porcausa dos efeitos colaterais sobre o sistema gastrintestinal, e naqueles com dificuldades de adaptação ao tratamento.

Comparison of different postoperative paın managements in patients submitted to transperitoneal laparoscopic renal and adrenal surgery

ABSTRACTPurpose:We compared the effects of local levobupivacaine infiltration, intravenous paracetamol, intravenous lornoxicam treatments on postoperative analgesia in patients submitted to transperitoneal laparoscopic renal and adrenal surgery.Materials and Methods:Sixty adult patients 26 and 70 years who underwent laparoscopic renal and adrenal surgery were randomized into three groups with 20 patients each: Group 1 received local 20mL of levobupivacaine 0.25% infiltration to the trocar incisions before skin closure. In group 2, 1g paracetamol was given to the patients intravenously 30 minutes before extubation and 5g paracetamol was given intravenoulsy in the 24 postoperative period. In group 3, 8mg lornoxicam i.v. was given 30 minutes before extubation and 8mg lornoxicam i.v. was given in the 24 postoperative period. In the postoperative period, pain scores, cumulative tramadol, and additional pethidine consumption were evaluated.Results:Postoperative pain scores significantly reduced in each group (p < 0.05). Although pain levels of the groups were not significantly different at 1, 2, 4, 8, 12 and 24 hours postoperatively, cumulative tramadol consumptions were higher in group 1 than the others. (Group 1 = 370.6 ± 121.6mg, Group 2: 220.9 ± 92.5mg, Group 3 = 240.7 ± 100.4mg.) (p < 0.005). The average dose of pethidine administered was significantly lower in groups 2 and 3 compared with group 1 (Group 1: 145mg, Group 2: 100mg, Group 3: 100mg) (p = 0.024).Conclusions:Levobupivacaine treated group required significantly more intravenous tramadol when compared with paracetamol and lornoxicam groups in patients submitted to transperitoneal laparoscopic renal and adrenal surgery.

Evaluation of protein undernourishment on the condylar process of the Wistar rat mandible correlation with insulin receptor expression

The mandible condylar process cartilage (CP) of Wistar rats is a secondary cartilage and acts as a mandibular growth site. This phenomenon depends on adequate proteins intake and hormone actions, including insulin. Objectives The present study evaluated the morphological aspects and the expression of the insulin receptor (IR) in the cartilage of the condylar process (CP) of rats subjected to protein undernourishment. Material and Methods The nourished group received a 20% casein diet, while the undernourished group (U) received a 5% casein diet. The re-nourished groups, R and RR, were used to assess the effects of re-nutrition during puberty and adulthood, respectively. CPs were processed and stained with picro-sirius red, safranin-O and azocarmine. Scanning electron microscopy and immunohistochemistry were also performed. Results The area of the CP cartilage and the number of cells in the chondroblastic layer decreased in the U group, as did the thickness of the CP layer in the joint and hypertrophic layer. Renourishment during the pubertal stage, but not during the adult phase, restored these parameters. The cell number was restored when re-nutrition occurred in the pubertal stage, but not in the adult phase. The extracellular matrix also decreased in the U group, but was restored by re-nutrition during the pubertal stage and further increased in the adult phase. IR expression was observed in all CPs, being higher in the chondroblastic and hypertrophic cartilage layers. The lowest expression was found in the U and RR groups. Conclusions Protein malnutrition altered the cellularity, the area, and the fibrous cartilage complex, as well as the expression of the IRs. .

Lornoxicam versus tramadol for post-operative pain relief in patients undergoing ENT procedures

Pain following ear-nose and throat surgery is one of the most important complaints for which, several drugs are used. This prospective, randomized, double-blind controlled trial was designed to compare the analgesic effect of tramadol versus lornoxicam for post-operative pain relief in patients undergoing ENT surgical procedures. One hundred and twenty patients of ASA class I-II, who had undergone elective ENT surgical procedures under general anesthesia, were assigned in a randomized manner into three equal groups. Group L received lornoxicam8 mg IV, Group T received tramadol 1 mg/kg IV and Group C received IV saline after induction of anesthesia before the start of the surgery. Post-operative pain was assessed using the visual analogue scale [VAS] and sedation level was evaluated during stay in the post-anesthesia care unit with a four-point sedation scale. Intraoperative blood loss was estimated using the Five-Point Scale. Adverse events in the first 24 h post-operative were recorded. The VAS pain scores were significantly higher in Group C as compared with those in Groups L and T at 30 min and 1, 2, 4and 6 h post-operatively, with no significant difference between Group L and Group T. The amount of morphine consumption post-operatively was significantly lower in Group L [5.2 +/- 2.5 mg] and Group T [5.0 +/- 2.0 mg] as compared with that in Group C [7.4 +/- 2.3 mg] [P = 0.001]. The time for the first analgesic requirement was significantly less in Group L [92.62 +/- 24.23 min] and Group T [88 +/- 21.43 min] as compared with that in Group C [42.82 +/- 25.61 min], with no significant difference between the other two groups. Estimated intraoperative blood loss score by the surgeons showed no significant difference between the three groups. The most frequent side-effects in the three groups were nausea and vomiting, and their incidence was significantly higher in the placebo group as compared with the other two groups. Tramadol 1 mg/kg was comparable to lornoxicam 8 mg for post-operative pain relief in patients undergoing ENT surgical procedures; both drugs helped to reduce the post-operative opioid requirement and consequently minimized the related adverse effects of the opioids

Comparação de lornoxicam e fentanil adicionados à lidocaína em anestesia regional intravenosa / Comparison of lornoxicam and fentanyl when added to lidocaine in intravenous regional anesthesia / Comparación de lornoxicam y fentanilo adicionados a la lidocaína en la anestesia regional intravenosa

JUSTIFICATIVA E OBJETIVO: Comparar os efeitos analgésicos nos períodos intra e pós-operatório de lornoxicam e fentanil adicionados à lidocaína para anestesia regional intravenosa (ARIV) em um grupo de pacientes submetidos à cirurgia de mão. MÉTODOS: Estudo randômico, duplo-cego e controlado. Foram incluídos e randomizados 45 pacientes em três grupos: o Grupo I recebeu 3 mg.kg-1 de lidocaína a 2% (40 mL); o Grupo II recebeu 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de lornoxicam; o Grupo III recebeu 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de fentanil. O desfecho primário avaliado foi o tempo até a primeira necessidade de analgésicos no pós-operatório. RESULTADOS: Lornoxicam adicionado à lidocaína em ARIV aumentou o tempo de recuperação do bloqueio sensorial sem aumentar os efeitos colaterais, e o tempo até a primeira necessidade de analgésicos no pós-operatório em comparação com lidocaína sozinha (p < 0,001, p < 0,001, respectivamente) e fentanil adicionado à lidocaína (p < 0,001, p < 0,001, respectivamente). Além disso, também descobrimos que fentanil diminuiu a dor ocasionada pelo torniquete (p < 0,01) em comparação com lidocaína, mas mostrou efeito analgésico similar ao de lornoxicam (p > 0,05), embora os escores da escala visual analógica (EVA) relacionados à dor ocasionada pelo torniquete tenham sido menores no grupo fentanil. Lornoxicam adicionado à lidocaína em ARIV não foi superior à lidocaína sozinha para diminuir a dor ocasionada pelo torniquete. CONCLUSÃO: A adição de fentanil à lidocaína em ARIV parece ser superior à lidocaína sozinha e ao lornoxicam adicionado à lidocaína para diminuir a dor ocasionada pelo torniquete, apesar de aumentar os efeitos secundários. No entanto, lornoxicam não aumentou os efeitos secundários e proporcionou analgesia nos períodos tanto intraoperatório quanto pós-operatório. Portanto, lornoxicam pode ser mais adequado para o uso clínico.

BACKGROUND AND OBJECTIVES: In this study, our goal was to compare intraoperative and postoperative analgesic effects of lornoxicam and fentanyl when added to lidocaine Intravenous Regional Anesthesia (IVRA) in a group of outpatients who underwent hand surgery. METHODS: This is a double blind randomized study. A total of 45 patients were included, randomized into three groups. Patients in Group I (L) received 3 mg.kg-1 of 2% lidocaine 40 mL; patients in Group II (LL) received 3 mg.kg-1 lidocaine 38 mL + 2 mL lornoxicam; patients in Group III (LF) received 3 mg.kg-1 lidocaine 38 mL + 2 mL fentanyl. Our primary outcome was first analgesic requirement time at postoperative period. RESULTS: Lornoxicam added to lidocaine IVRA increased the sensory block recovery time without increasing side effects and increased first analgesic requirement time at the postoperative period when compared to lidocaine IVRA (p < 0.001, p < 0.001 respectively) and fentanyl added to lidocaine IVRA (p < 0.001, p < 0.001 respectively). In addition, we also found that fentanyl decreased tourniquet pain (p < 0.01) when compared to lidocaine but showed similar analgesic effect with lornoxicam (p > 0.05) although VAS scores related to tourniquet pain were lower in fentanyl group. Lornoxicam added to lidocaine IVRA was not superior to lidocaine IVRA in decreasing tourniquet pain. CONCLUSIONS: Addition of fentanyl to lidocaine IVRA seems to be superior to lidocaine IVRA and lornoxicam added to lidocaine IVRA groups in decreasing tourniquet pain at the expense of increasing side effects. However, lornoxicam did not increase side effects while providing intraoperative and postoperative analgesia. Therefore, lornoxicam could be more appropriate for clinical use.

JUSTIFICATIVA Y OBJETIVO: Comparar los efectos analgésicos en los períodos intra y postoperatorio del lornoxicam y del fentanilo adicionados a la lidocaína para la anestesia regional intravenosa (ARIV), en un grupo de pacientes sometidos a la cirugía de mano. MÉTODOS: Estudio aleatorio, doble ciego y controlado. Fueron incluidos y aleatorizados por el equipo de investigación 45 pacientes en tres grupos: el Grupo I recibió 3 mg.kg-1 de lidocaína al 2% (40 mL); el Grupo II recibió 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de lornoxicam; el Grupo III recibió 3 mg.kg-1 de lidocaína (38 mL) + 2 mL de fentanilo. El resultado primario evaluado fue el tiempo hasta la primera necesidad de analgésicos en el postoperatorio. RESULTADOS: El Lornoxicam adicionado a la lidocaína en ARIV aumentó el tiempo de recuperación del bloqueo sensorial, sin aumentar los efectos colaterales y el tiempo hasta la primera necesidad de analgésicos en el postoperatorio en comparación con la lidocaína sola (p < 0,001, p < 0,001, respectivamente) y el fentanilo adicionado a la lidocaína (p < 0,001, p < 0,001, respectivamente). Además de eso, también descubrimos que el fentanilo redujo el dolor ocasionado por el torniquete (p < 0,01) en comparación con la lidocaína, pero mostró un efecto analgésico parecido con el del lornoxicam (p > 0,05), aunque las puntuaciones de la escala visual analógica (EVA) relacionadas con el efecto ocasionado por el torniquete, hayan sido menores en el grupo fentanilo. El Lornoxicam adicionado a la lidocaína en ARIV no fue superior a la lidocaína sola para reducir el dolor ocasionado por el torniquete. CONCLUSIÓN: Podemos decir que la adición del fentanilo a la lidocaína en ARIV parece ser superior a la lidocaína sola y al lornoxicam adicionado a la lidocaína para disminuir el dolor ocasionado por el torniquete, a pesar de aumentar los efectos secundarios. Sin embargo, el lornoxicam no aumentó los efectos secundarios, proporcionando una analgesia en los períodos tanto intraoperatorio como postoperatorio. Por tanto, el lornoxicam puede ser más adecuado para el uso clínico.

Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial / Fentanil peridural versus venoso na analgesia pós-operatória de cirurgia ortopédica: ensaio clínico aleatório

CONTEXT AND OBJECTIVE: Controversy exists regarding the site of action of fentanyl after epidural injection. The objective of this investigation was to compare the efficacy of epidural and intravenous fentanyl for orthopedic surgery. DESIGN AND SETTING: A randomized double-blind study was performed in Hospital São Paulo. METHODS: During the postoperative period, in the presence of pain, 29 patients were divided into two groups: group 1 (n = 14) received 100 µg of fentanyl epidurally and 2 ml of saline intravenously; group 2 (n = 15) received 5 ml of saline epidurally and 100 µg of fentanyl intravenously. The analgesic supplementation consisted of 40 mg of tenoxicam intravenously and, if necessary, 5 ml of 0.25 percent bupivacaine epidurally. Pain intensity was evaluated on a numerical scale and plasma concentrations of fentanyl were measured simultaneously. RESULTS: The percentage of patients who required supplementary analgesia with tenoxicam was lower in group 1 (71.4 percent) than in group 2 (100 percent): 95 percent confidence interval (CI) = 0.001-0.4360 (P = 0.001, Fisher's exact test; relative risk, RR = 0.07). Epidural bupivacaine supplementation was also lower in group 1 (14.3 percent) than in group 2 (53.3 percent): 95 percent CI = 0.06-1.05 (P = 0.03, Fisher's exact test; RR = 0.26). There was no difference in pain intensity on the numerical scale. Mean fentanyl plasma concentrations were similar in the two groups. CONCLUSION: Intravenous and epidural fentanyl appear to have similar efficacy for reducing pain according to the numerical scale, but supplementary analgesia was needed less frequently when epidural fentanyl was used.

CONTEXTO E OBJETIVO: Existem controvérsias sobre o local de ação do fentanil injetado por via peridural. O objetivo foi comparar a eficácia do fentanil peridural e do venoso em cirurgias ortopédicas. TIPO DE ESTUDO E LOCAL: Estudo aleatório, duplo-cego, realizado no Hospital São Paulo. MÉTODO: No pós-operatório, na presença de dor, 29 pacientes foram divididos em dois grupos: grupo 1 (n = 14) recebeu solução de 100 mcg de fentanil por via peridural e 2 ml de solução salina venosa; grupo 2 (n = 15), 5 ml de solução salina peridural e 100 µg de fentanil venoso. A complementação analgésica foi com 40 mg de tenoxicam venoso e, se necessário, 5 ml de bupivacaína 0.25 por cento. A intensidade da dor foi avaliada pela escala numérica e a concentração plasmática do fentanil foi medida simultaneamente. RESULTADOS: A percentagem de pacientes que necessitaram de complementação analgésica com tenoxicam foi menor no grupo 1 (71.4 por cento versus 100.0 por cento grupo 2): intervalo de confiança, IC 95 por cento = 0.001-0.4360 (P = 0.001, teste exato de Fisher; risco relativo, RR = 0.07). A complementação com bupivacaína peridural também foi menor no grupo 1 (14.3 por cento versus 53.3 por cento grupo 2): IC 95 por cento = 0.06-1.05 (P = 0.03, teste exato de Fisher; RR = 0.26). Não houve diferença na intensidade da dor avaliada pela escala numérica. As concentrações plasmáticas do fentanil foram semelhantes nos dois grupos. CONCLUSÃO: A eficácia do fentanil venoso e peridural parece ser semelhante na redução da dor de acordo com a escala numérica, porém a frequência de analgesia suplementar foi menor com o uso do fentanil peridural.

Lornoxicam efficacy in acute pain (LEAP) trial.

Parenteral non-steroidal anti-inflammatory drugs (NSAIDs) are useful agents in the treatment of postoperative pain and other acute traumatic painful conditions such as fractures. Clinical trials with lornoxicam, an oxicam derivative, document its efficacy as a potent analgesic with excellent anti-inflammatory properties in painful and or/inflammatory conditions including postoperative pain and arthritic conditions. However, there is no documentation of the efficacy and tolerability of intravenous lornoxicam in Indian patients with acute painful conditions such painful traumatic conditions requiring hospitalisation and parenteral analgesics. The present study was undertaken to evaluate the efficacy and tolerability of intravenous lornoxicam in Indian patients with postoperative pain or other acute painful traumatic conditions requiring hospitalisation and parenteral analgesia in in-office practice conditions. In this multicentric, prospective, open, non-comparative phase IV, postmarketing surveillance study patients admitted in the nursing home for either postoperative pain or painful conditions requiring hospitalisation and parenteral analgesia were enrolled in the study after obtaining their informed consent. Of the 161 patients fulfilling the selection criteria, 148 met the selection criteria and were included in the efficacy analysis. Patients were treated with intravenous lornoxicam 8 mg twice or three times daily as required for up to 3 days. Efficacy variables included changes in severity of pain scores compared to baseline values, onset of pain relief and overall global efficacy. Tolerability was assessed through monitoring of treatment-emergent adverse events, physical examination, assessments of vital signs, and overall global assessment of tolerability. Results indicated that within 1 hour of administration of intravenous lornoxicam, the mean scores of pain severity were reduced by 39.46% and by 6 hours, there was a further 52% reduction in the mean scores. Therapy with intravenous lornoxicam was associated with a faster onset of action with 15.4% patients reporting pain relief within 10 minutes and 55.9% patients within 10 to 30 minutes. Overall, global assessment of efficacy was rated as good to excellent in 95.3% of the patients. Therapy with intravenous lornoxicam was well tolerated with only 5 patients reporting adverse events such as headache (n=3) and gastritis (n=1) of mild to moderate intensity but transient. Overall, global tolerability was rated as good to excellent in 98.4% of the total cases and fair in only 1.6% of the cases. In conclusion, the results of the present study indicate that intravenous lornoxicam is a potent NSAID with an optimal efficacy/toxicity ratio and thus could be a suitable therapeutic option in the management of patients with painful traumatic conditions requiring parenteral NSAIDs and hospitalisation.

Effect of intraarticular injection of lornoxicam on the articular cartilage & synovium in rat.

BACKGROUND & OBJECTIVE: Intraarticular (i.a) drug application is consider to be a new therapeutic approach for the treatment of postoperative pain after arthroscopic knee surgery without any systemic adverse effects. Lornoxicam, a nonsteroid anti-inflammatory drug is a short acting agent, and its anti-inflammatory and analgesic activity may be effective in the postoperative pain management in minor surgery. In this study, the effects of intraarticular administration of lornoxicam on the synovium and articular cartilage in the rat knee joint were investigated. METHODS: Lornoxicam (0.25 ml) was given as an injection into the right knee joint and 0.25 ml of 0.9 per cent saline solution by injection into the left knee joint as a control in 25 rats. Groups of five rats were sacrificed by a lethal injection of ketamine 1st, 2nd, 7th, 14th and 21st days after lornoxicam administration. Knee joints were detached, fixed in 10 per cent buffered formalin and decalcified. Serial sections of 5 microm were stained with haematoxylin-eosin and evaluated for the presence of inflammation in the articular, periarticular regions and synovium. Inflammatory changes in the joints were graded according to a five-point scale, histologically. RESULTS: There were no significant differences in inflammation and cartilage degeneration, between control and lornoxicam applied knees. Grade 3 inflammatory changes occurred only in one knee in lornoxicam group, at 24 h after injection. No pathological changes were observed in both groups at any time point. INTERPRETATION & CONCLUSION: Lornoxicam did not show significant effect on inflammation on rat synovia in knee joint. Further studies including in human need to be done before any recommendations are made for i.a. administration of lornoxicam.

Comparative study of different doses and routes of administration of lornoxicam for peri-operative analgesia in patients undergoing intravenous regional anesthesia for minor upper arm surgery

The use of perioperative NSAIDs has become popular in operation ranging from minor outpatient to major inpatient surgery. A systemic review suggested that NSAIDs have the most to offer as adjuncts to intravenous regional anesthesia. Lornoxicam has demonstrated clinical efficacy in relieving pain, through different routes of administrations, oral, IM, IV, and local infiltration. In this study comparison of different doses and routes of administration of Lornoxicam for peri-operative analgesia in patients undergoing intravenous regional anesthesia for minor upper arm surgery was done. 60 patients ASA 1 and 2 undergoing minor upper limb surgeries were studied Patients were randomly divided into six groups; Group I: Total volume of 40ml of pre-prepared Local intravenous solution mixed with 8mg of Lornoxicam. Group 2: Total volume of 40ml of pre-prepared Local intravenous solution mixed with 16mg of Lornoxicam. Group 3: Total volume of 40ml of pre-prepared Local intravenous solution plus Lornoxicam 8mg intramuscular. Group 4: Total volume of 40ml of pre-prepared Local intravenous solution plus Lornoxicam 16mg intramuscular. Group 5: Total volume of 40ml of pre-prepared Local intravenous solution plus Lornoxicam 8mg intravenously. Group 6: Total volume of 40ml of pre-prepared Local intravenous solution plus Lornoxicam 16mg intravenously. Better qualities of block, less tourniquet pain, and better quality of postoperative analgesia were found in groups 1, 2 that had lornoxicam combined with lidocaine compared with other groups used lornoxicam intravenously or intramuscular [p<0.05]. Moreover, using lornoxicam 16mg proved to be better than lornoxicam 8mg when combined with total intravenous solution [p<0.05]. Lornoxicam used in the local intravenous solution gave better quality of intraoperative condition and postoperative analgesia without increase in the incidence of side effects compared with lornoxicam used intramuscularly or intravenously. Also lornoxicam 16mg provide better intraoperative analgesia compared to lornoxicam 8mg when both were used locally with local intravenous regional analgesia

Structure investigation of piroxicam and tenoxicam using thermal analyses, mass spectrometry and semi-empirical MO calculations

Steroidal and non-steroidal anti-inflammatory agents such as oxicam group [e.g. piroxicam [Pir] and tenoxicam [Ten] were investigated using thermal analyses [TA] measurements [TGA, DTGA, DTA and DDTA] in comparison with El mass spectral [MS] fragmentation at 70 eV. Semi-emperical molecular orbital [MO] calculations have been carried out using PM3 described by Stewart on Pir and Ten both as neutral molecules and the corresponding positively charged molecular ions. These calculations included molecular geometries such as bond length, bond order, bond strain, atomic charge distribution and hybridization, and heat of formation of these drugs. Thermal analyses reveal a high response of Pir and Ten to temperature variation with a cleavage of six bonds in aliphatic side chains around O, S, and N heteroatom, leaving aromatic radicals as final products, which become volatile at high temperature. TA mostly involved fragmentation of SO2 gas molecule at first followed by C, N, and O containing fragments as CH3CN, CHO, NHCONHCO, and NHCO. The MS fragmentations indicate the presence of the same final products as given by TA technique. Mass fragmentation pathways refer to the loss of more or less the same fragments via cleavage of seven bonds of Pir and nine bonds of Ten molecular ions, in parallel and many consecutive steps as explained by geometries values calculated by MOC. These may refer to the instability of Pir and Ten molecular ions in comparison with their neutral forms. This instability is explained by comparison of the calculated partial charges on their atoms and/or their heat of formation values. The best pathway in both TA and MS techniques is that starts with the loss of SO2 gas molecule and followed by the loss of HCO and CH3CN molecules. The partial charge values and the stereo structures of ionic and neutral form refer to a distinct phenomenon of collection of voluminous charge density on SO2 group covering in space most atoms behind. It is explained by the highest electron withdrawing abilities of the heteroatom, two O and S in this group as a result of their high electro negativities. This rationalized the starting of fragmentation process in TA and MS with the loss of SO2 gas molecules. Therefore, a MOC was applied to declare both TA and MS observations

Efeitos do Tenoxicam sobre a cicatrização da parede abdominal: estudo experimental em ratos / Effects of Tenoxicam on the abdominal wall healing: experimental study in rats

OBJETIVO: Analisar os efeitos do tenoxicam, um antiinflamatório não hormonal, na cicatrização da parede abdominal de ratos. MÉTODOS: Foram utilizados 40 ratos adultos, submetidos à laparotomia mediana e distribuídos, aleatoriamente, em um grupo controle (C), constituído de 20 animais que receberam solução de NaCl a 0,9 por cento; e um grupo tratado (T), constituído de 20 animais que receberam o tenoxicam. Os animais de cada grupo foram divididos, conforme a data de sacrifício, em subgrupos de 10 animais, denominados C7, C14, T7 e T14. As inscrições 7 e 14 determinaram o sacrifício dos animais no sétimo e décimo quarto dia pós-operatório, respectivamente. As soluções de tenoxicam (1mg/ml) e de NaCl a 0,9 por cento foram administradas no pós-operatório imediato e nos quatro dias seguintes, por via intramuscular, na dose volume de 0,6 ml/kg/dia. No dia do sacrifício, realizou-se a ressecção de dois fragmentos da parede abdominal (1cm x 3cm), que foram utilizados para determinação da concentração de hidroxiprolina e avaliação da força de ruptura. RESULTADOS: Não foram observadas complicações da ferida operatória, incluindo infecção ou deiscência, nos quatro subgrupos de animais. Na análise comparativa dos quatro subgrupos de animais, não foi evidenciada diferença estatisticamente significante no estudo da força de ruptura (p=0,262) e na concentração de hidroxiprolina (p=0,392). CONCLUSÃO: A administração de tenoxicam, por via intramuscular, não interfere na cicatrização da parede abdominal de ratos.

Treatment of pain after spinal surgery in the recovery room by single dose lornoxicam: a randomized, double blind, placebo-controlled trial.

BACKGROUND: Lornoxicam has been used in microsurgical lumbar discectomy. However, there is no data about controlling pain after open discectomy or laminectomy. OBJECTIVE: To compare the efficacy of a single dose of 16 mg of lornoxicam for the treatment of pain after disectomy or laminectomy with placebo in the PACU. STUDY DESIGN: Randomized, double blind, placebo-controlled trial. MATERIAL AND METHOD: Fifty-six patients who underwent discectomy or laminectomy were randomly allocated to receive 16 mg lornoxicam (Group L), or placebo (Group P) at the beginning of wound closure. Pain scores at rest (using a verbal numeric rating scale: VNRS 0-10), time to first analgesia requirement, morphine consumption during the first 2 hr after surgery and adverse effects were all recorded. The outcomes were assessed on admission to the PACU (T0), then at 1 (T1) and 2 (T2) hr after surgery. RESULTS: Baseline data were comparable between the two groups. The proportion of patients with VNRS > 5 at T0 in both groups were not significantly different (44.4% in group P vs 50.0% in group L, CI of difference: - 32.4%, 21.3%, p = 0.68). The mean VNRS scores, at T0 and T1 were > 5 and at T2 was < 5 in both groups. There was no difference between the two groups. The morphine consumption in both groups was not different (9.0 mg vs 9.3 mg) as well as the time to first analgesia requirement (35 min vs 40 min). Patients in the two groups had no significant difference in the symptoms or degree of nausea/vomiting. The number of patients with excessive sedation and the proportion of patients needing oxygen during transportation to the ward were not different. CONCLUSION: Lornoxicam 16 mg given intravenously before wound closure provides inadequate pain relief immediately after disectomy or laminectomy in the PACU. However, adequate pain relief was demonstrated at 2 hr after surgery, which was similar to the placebo.

Comparaçäo ente a administraçäo de tenoxicam no pré e no pós-operatório de hemorroidectomias / Comparison between preoperative and postoperative tenoxican in hemorrhoidectomies

Justificativa e objetivos: analgesia preventiva utilizando antiinflamatórios näo esteróides tem sido utilizado em diversos tipos de procedimentos cirúrgicos, com resultados variáveis. Este estudo prospectivo, duplo-encoberto teve como objetivo comparar os padröes de dor pós-hemorroidectomia quando o tenoxican é administrado antes ou depois do trauma cirúrgico. Método: participaram do estudo 24 pacientes com idades entre 18 e 65 anos, estado físico ASA I e II, submetidos a hemorroidectomias divididos por prévio sorteio em dois grupos: grupo I (tenoxican, 20mg por via venosa, 15 minutos antes do início da anestesia) e grupo II (tenoxican, 20mg por via venosa, imediatamente após o término da cirurgia). A dor pós-operatória foi medida pela escala analógica visual. Da mesma maneira foi avaliada a dor durante evacuaçäo. Resultados: näo houve diferenças estatisticamente significativas entre os grupos quanto à intensidade da dor às 10, 24, 48 e 72 horas do período pós-operatório, ou durante a primeira evacuaçäo. Conclusöes: o tenoxican, administrado por via venosa, precedendo o trauma cirúrgico em hemorroidectomias, näo diminui a dor pós-operatória nem a que acompanha a primeira evacuaçäo, comparado a sua administraçäo imediatamente após o término da cirurgia

Effect of tenoxican on inflammation and immune cellular function

1. We have shown that nonsteroidal anti-inflammatory drugs are potent inhibitors of neutrophil activation. tenoxican is a new compound of the oxican family which has been shown to be effective for routine clinical use. 2. In the present study we examined the immune pharmacological effects of this compound on lymphocyte function by determining its efffect on the expression of IL-2 receptors, on monocyte function by looking at chemotaxis and IL-1 release and on release and on neutrophil function by evaluating the chemotactic response to a standard stimulus. 3. The data show that Tenoxican inhibits the neutrophil and monocyte functional chemotactic response in vitro, and to some extent in vivo for monocytes, but has no effect onthe expression of IL-2 receptors or IL-1 release. Tenoxicam inhibits the mobilization of neutrophils and monocytes to inflamatory sites, even thought this effect was not clearly demonstrable when cells were tested after oral use

Estudio doble-ciego paralelo, comparativo con tenoxican vs. placebo in acute gouty arthritis / A comparative, double-blind parallel. study with tenoxicam vs. placebo in acute gouth arthritis

En el presente trabajo se hizo un estudio doble-ciego paralelo en el que se utilizó tenoxicam vs placebo para el tratamiento de 30 pacientes con manifestaciones de artritis gotosa aguda. Se incluyeron al azar 15 pacientes en cada grupo y el medicamento se administró en una dosis única diaria de 40 mg, o placebo de aparencia idéntica, durante cuatro días. Al final del tratamiento con tenoxicam o placebo, se observó mejoría del síntoma dolor (espontáneo, a la palpación, y a la movilización de la articulación afectada) en la mayor parte de los pacientes, así como también de algunas manifestaciones clínicas objetivas como fueron calor local, inflamación y enrojecimiento articular. Sin embargo, el comienzo de la mejoría fue más rápido en el grupo tratado con tenoxicam, y esta diferencia fue estadísticamente significativa después de un día de tratamiento para el dolor en sus diferentes modalidades en que fue valorado. Aunque la eficacia juzgada por el médico reveló clara tendencia a favor de tenoxicam, el análisis de resultados no mostró una diferencia significativa entre los dos grupos al final de los cuatro días de tratamiento. Por último, tenoxicam fue bien tolerado y no se observaron reacciones clínicas adversas con el uso de este medicamento, por lo que puede anticiparse su administración con buenos resultados en los padecimientos reumáticos de tipo inflamatório