Development of a guar gum film with lysine clonixinate for periodontal treatments.

Periodontal pain is a public health problem derived from different conditions, including periodontal diseases, prosthetic complications, and even extractions performed by dentist. There are various treatments to control acute dental pain, being the administration of analgesics, such as Lysine Clonixinate (LC), a common practice. Unfortunately, higher and repeated dosages are usually required. The purpose of this work was to develop a prolonged release pharmaceutical form as an alternative treatment for dental pain. Hence, we conceived a film based on guar gum and loaded different concentrations of LC. We evaluated the film's appearance, brittleness, strength, and flexibility, and then chose one formulation for adequate characteristics. Subsequently, we assessed the morphology, thermal behavior, and swelling properties of the films (LC-free and -loaded). Finally, we performed the release studies of LC from the films in vitro using a simulated saliva medium and employed several mathematical models to evaluate the release kinetics. Guar gum is a natural polymer obtained from the endosperm of Cyamopsis tetragonolobus that presents properties such as biosafety, biocompatibility, and biodegradability. Thus, it represents a potential excipient for use in pharmaceutical formulations. Moreover, our results revealed that the LC-loaded film presented a high adherence, suitable swelling behavior, high LC content, and a prolonged drug release. Therefore, the LC-loaded film may be considered a potential option to be applied as an alternative to treat dental pain.

Cortisol, progesterone, 17αOHprogesterone, and pregnenolone in foals born from mare's hormone-treated for experimentally induced ascending placentitis.

This study aimed to evaluate steroid hormones in foals born from mares treated for ascending placentitis with different combinations of trimethoprim-sulfamethoxazole (TMS), flunixin meglumine (FM), long-acting altrenogest (ALT) and estradiol cypionate (ECP) for ten consecutive days, starting two days after experimental induction of placentitis with Streptococcus zooepidemicus. Fourty-six pregnant mares and respective foals were assigned as healthy group (Control, n = 8) or treated groups as follows: TMS+FM (n = 8), TMS+FM+ALT (n = 8), TMS+FM+ALT+ECP (n = 6), TMS+FM+ECP (n = 6) and no treatment (NO TREAT n = 10). At delivery, foals were classified as high-risk or low-risk based on clinical and hematologic findings, and survival rates were recorded during the first week of life for comparisons across groups. Cortisol, progesterone, 17αOHprogesterone, and pregnenolone concentrations were determined via immunoassays in 31 of the 46 foals immediately after foaling (0 h), at 12, 24, 48 h, and seven days post-partum (168h). At birth, serum cortisol concentrations were higher in Control and TMS+FM+ECP foals than in remaining groups (p < 0.05). Foals in TMS+FM+ALT and TMS+FM groups had higher 17αOHprogesterone concentrations at 24 h and 48 h, respectively (p < 0.05). Pregnenolone concentrations were higher in TMS+FM than TMS+FM+ALT+ECP foals at 7 days (p < 0.05). High-risk and non-surviving foals had decreased concentrations of cortisol at parturition, but increased concentrations of progesterone from 0 h to 48 h. Pregnenolone and 17αOHprogesterone concentrations were increased and pregnenolone after 12 h in high-risk and non-surviving foals (p < 0.05). In conclusion, adding ECP to the treatment of experimentally-induced placentitis appears to improve foal viability and endocrine response. Cortisol and progestogen profiles were abnormal in high-risk and non-surviving foals, and those treated with ALT or TMS+FM only.

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.

Analgesic efficacy of lysine clonixinate, paracetamol and dipyrone in lower third molar extraction: a randomized controlled trial.

OBJECTIVE: The purpose of this study is to compare the analgesic effect of lysine clonixinate, paracetamol and dipyrone after lower third molar extraction. MATERIAL AND METHODS: The sample consisted of 90 individuals with clinical indication for inferior third molar extraction. The mean age of the sample was 22.3 years (DP +/-2.5). The individuals received the medication in unidentified bottles along with the intake instructions. The postoperative pain parameters were measured according to the Visual Analogical Scale (VAS) and the data was evaluated using the Kruskal-Wallis Test and Friedman Test, with the latter used to test different time intervals for each one of the drugs. RESULTS: The final sample consisted of 64 individuals, including 23 males (45.9%) and 41 females (64.1%) The mean age of the entire sample was 22.3 years (+/-2.5). The average length of the procedures was 33.9 minutes (+/-9.8). The distribution of mean values for this variable showed little variance for the different drugs (p=0.07). CONCLUSION: Lysine Clonixinate did not show any substantial impact on the postoperative pain control when compared to other drugs.

Lysine clonixinate versus dipyrone (metamizole) for the acute treatment of severe migraine attacks: a single-blind, randomized study.

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% of the dipyrone group 13% of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13%) and 5 (33%) patients from the dipyrone group and 11 (73%) and 13 (86.7%) 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.

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.

Efecto analgésico comparativo del clonixinato de lisina y paracetamol en intervenciones odontológicas menores / Clonixinato comparative analgesic effect of lysine and acetaminophen in dental procedures under

Alvarez Falconi P. P. Novoa Lias E. Eecto analgésico comporativo del Clonixinato de lisina y paracetamol en intervenciones odontológicas menores. Rev Farmacol Terap (Lima) 5(1-2): 84-86, 199, en un ensayo clínico doble ciego, en 18 pacientes entre 22 a 60 años, divididos en 2 grupos de 9, se comparó la eficacia analgésica y tolerancia de 125 mg. de Clonixinato de lisina versus 500mg. de paracetamol, administrados por vía oral 3 veces al día por tres días, en el tratamiento del dolor subsecuente a intervenciones odontologías menores. La medición del dolor espontáneo se determinó en una escala de 0 a 10. Clonixinato de Lysina mostró mayor eficacia analgésica que Paracetamol alcanzando un valor comporativo porcentual significativo, p<0.01. No se notificaron reacciones adversas. La disminución más rápida y efectiva de las molestias dolorosas en los pacientes de Clonixinato de lisina mejoró su relación humana, la reiniciación de sus comunicaciones verbales, la ingesta de alimentos y la reincorporación a sus actividades laborales.

Alvarez Falconi P. P. Novoa Lias E. comportive analgesic effect of lisien Cloxinate and Paracetamol in minor dental intervention. Rev Farmacol Terap (Lima) 5 (1-2): 84-86, 199, in a double blinded clinical study of 18 patients among 22 to 60 years of age, divided in 2 groups of 9 each, It was administered 125 mg. of lysine Clonixinato versus Paracetamol 500mg. , by oral route 3 times daily for three days for each group, for pain due to minor dental interventions. Pain was evaluated for scale from 0 to 10. Lysine Clonixinate showed better analgesic activation than paracetamol reaching a comparative per cent value, p <0.01. No adverse reactions were informed. Patients that received lysine Cloxinate had more rapid human verbal relationships and improve feeding and promt this labor activities.

Lysine clonixinate vs naproxen sodium for the acute treatment of migraine: a double-blind, randomized, crossover study.

BACKGROUND AND OBJECTIVES: The process of inflammation is crucial in migraine, and several nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in the treatment of migraine attacks. Despite their efficacy, the routine use of NSAIDs is limited by side effects as well as incomplete efficacy in some patients. Among the available options, lysine clonixinate (LC) and naproxen sodium (NS) have proved effective in migraine. The aim of this study was to compare the efficacy and tolerability of oral formulations of LC and NS in the treatment of moderate or severe migraine attacks, with a double-blind, crossover design. METHODS: Seventy subjects (62 women, 8 men) between ages 18 and 71 years (mean age, 41) with migraine according to the criteria of the International Headache Society were prospectively enrolled. The patients were randomized into 2 groups and each participant treated 2 migraine attacks. Group 1 treated the first attack with LC and the second attack with NS. Group 2 treated 2 attacks in a counterbalanced order. Doses were 250 mg of LC or 550 mg of NS, which were encapsulated for equal appearance. Headache intensity, nausea, photophobia, and side effects were evaluated at baseline, 1 hour, and 2 hours after drug administration. Rescue drugs were allowed after 2 hours for those who didn't respond, and this was also compared between groups. RESULTS: Sixty patients (54 women, 6 men) completed the study. At 1 hour, 13.6% patients who used LC were pain-free compared with 11.9% who used NS (P = .78). At 2 hours, 35.6% patients who took LC and 32.2% who took NS were pain-free (P = .69). At baseline, 52.5% of the patients randomized to group 1 reported nausea, compared with 33.9% in group 2, and both drugs eliminated nausea: At both 1 hour and 2 hours, nausea diminished significantly for those taking LC, but only after 2 hours for those who took NS (P < .0001). Both drugs eliminated photophobia at 1 hour and 2 hours; however, LC was superior to NS in reducing photophobia at 2 hours (P = .027). Ten patients who took LC and 8 who took NS required rescue drugs after 2 hours. Twelve patients who used LC and 16 who took NS reported side effects. COMMENTS: Although this study did not include a placebo arm, which impairs any definitive efficacy claims, we found LC and NS to be similarly effective and well tolerated in patients presenting moderate or severe attacks of migraine.

Kinetics of venom and antivenom serum and clinical parameters and treatment efficacy in Bothrops alternatus envenomed dogs.

Dogs envenomed with non-lethal doses of Bothrops alternatus venom received standard antivenom therapy, im injections of flunixin meglumine, or topical treatmentwith aqueous Curcuma longa plant extract. Biodistribution of the venom and antivenom were determined by ELISA. There was no significant difference in the efficacy of antivenom and plant extract on local effects; flunixin treatment had lower efficacy. Distribution of the venom was similar with all 3 treatments. Serum levels of the antivenom reached maximum 2-4 h after administration and were not detected after the 5th d.

Função renal de cães tratados com doses terapêuticas de flunixin meglumine e ketoprofen durante o trans e pós-operatório / Renal function in dogs treated with therapeutic dosages of flunixin meglumine and ketoprofen during the trans and pos-operatory period

Baseando-se em relatos de casos de falência renal após a administração de flunixin meglumine em animais saudáveis, o presente trabalho foi desenvolvido visando avaliar a função renal através da medição sérica de uréia e creatinina de quatro grupos de cinco caninos submetidos a um procedimento cirúrgico, sendo os dois primeiros tratados com flunixin meglumine e os dois seguintes tratados com ketoprofen, ambos em doses terapêuticas. Os valores séricos de uréia e creatinina mantiveram-se dentro dos limites fisiológicos, permitindo concluir que não há lesão renal em consequência da utilização tanto no trans quanto no pós-operatório de animais clinicamente sadios.

[Menstrual prostaglandin and dysmenorrhea: modulation by non-steroidal antiinflammatory drugs]. / Prostaglandinas menstruales y dismenorrea su modulación por antiinflamatorios no esteroideos.

The analgesic efficacy and tolerance of lysine clonixinate (LC) as well as LC-induced changes in menstrual prostaglandin levels were studied according to a prospective double-blind randomized crossover design, controlled with ibuprofen (I) and placebo (P). Treatment consisted in 4 consecutive phases: in the first phase, patients refrained from taking medication and during the remaining three phases, they received double-blind fixed doses of 1 tablet of lysine clonixinate 125 mg, I 400 mg or P, q.6 h. at random, three days before onset of menses and during 8 days thereafter. Controls were carried out at each menstrual cycle, assessing pain according to a scale from 0 to 4, onset of premenstrual and intramenstrual symptoms, relief of pain and occurrence of side-effects. During menstruation, patients recorded their assessments of pain in a diary and collected the whole menstrual bleeding during the first three days. The intensity of menstrual pain remained unchanged in controls upon admission (3.16) and during the phase with no treatment (3.04), but was significantly reduced with P (2.4), LC (1.79) and I (1.54). Significantly lower pain intensities compared with placebo were seen with active treatment phases. Forty-two percent of patients treated with P reported premenstrual pain which was significantly reduced to 17% with LC and to 12.5% with I. Active treatment phases revealed 21% of asymptomatic patients during premenstrual and menstrual periods and 71% (LC) and 75% (I) of cases with partial relief of pain. Patients' diaries showed significant pain reductions with LC and I, during the 1st and 2nd days compared with P; such differences were gradually reduced to nil by the 4th day. Levels of menstrual PGs changed according to pain intensity reductions from baseline (P: 29%, (NS); LC: 58% and I: 61%; both were statistically significant, p < 0.01).

[Intravenous lysine clonixinate for the treatment of migraine: an open pilot study]. / Clonixinato de lisina injetável intravenoso para o tratamento agudo das enxaquecas. Um estudo piloto aberto.

Several oral nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Despite its efficacy to treat migraine and other pain, there are a few commercial NSAIDs available for intravenous (i.v.) administration. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has been proven effective in various algic syndromes such as renal colic, nerve compression, muscular pain and odontalgias. The aim of this study was to evaluate the efficacy of the i.v. LC in the treatment of severe attacks of migraine. We studied prospectively 19 patients, 17 women and 2 men, ages from 18 to 57 years, with the diagnosis of migraine according to the International Headache Society criteria. The patients were oriented to proceed to the clinic once the headache has started, and were placed under an i.v. infusion of LC and saline in a superficial vein of the forearm, once the intensity reached severe. Evaluating the headache intensity after 30, 60 and 90 minutes, as well as the presence of side effects, we observed that all of the 19 patients were headache free after 90 minutes. Some patients presented mild adverse effects and the vital signs were not significantly affected. We then concluded that the i.v. infusion of the NSAID LC (2-3-chloro-o-toluidin)piridin-3-lysine carboxilate), a derived from the nicotinic acid with a chemical structure that resembles the flufenamic acid, was efficient abolishing a severe migraine attack after 90 minutes in 19 patients. Controlled studies with a double-blind and randomized design, and treating a greater number of patients and attacks are necessary to confirm these initial observations.

Efficacy and tolerance of lysine clonixinate versus paracetamol/codeine following inguinal hernioplasty.

In this study lysine clonixinate, a nonsteroidal antiinflammatory agent with selective inhibition of cyclooxygenase-2 and 5-lipooxygenase in in vitro and in vivo pharmacodynamic studies, was evaluated in a prospective, randomized, double-blind, double-dummy clinical study versus paracetamol/codeine, in 151 patients with pain following inguinal hernioplasty. Patients were treated with one 125 mg tablet of lysine clonixinate or paracetamol/codeine (500 mg + 30 mg) administered at fixed doses every 4 h during 2 days. Controls were carried out 1, 2 and 4 h after the first intake of day 1 and day 2. Each control included assessment of pain at rest, when coughing, sitting and upon moderate pressure. Both treatment groups (lysine clonixinate, 77 patients and paracetamol/codeine, 74 patients) were comparable in terms of demographic and baseline pain intensities. Spontaneous pain was reduced significantly in both treatment groups from the 1st-h control. The following values were recorded in the lysine clonixinate group during day 1: baseline: 6.86 +/- 1.24; 1st h: 4.49 +/- 1.77; 2nd h: 2.96 +/- 1.74; 4th h: 2.23 +/- 1.51. The following values for the same group during day 2 were: predose: 1.70 +/- 1.64; 1st h: 1.16 +/- 1.17; 2nd h: 0.78 +/- 1.06; 4th h: 0.63 +/- 1.05. The paracetamol/codeine group revealed the following values: day 1: baseline: 6.72 +/- 1.22; 1st h: 4.57 +/- 1.72; 2nd h: 2.97 +/- 1.68; 4th h: 2.47 +/- 1.68 and day 2: predose: 2.02 +/- 1.57; 1st h: 1.32 +/- 1.23; 2nd h: 0.82 +/- 0.99; 4th h: 0.66 +/- 0.89. Reduction of pain induced by coughing, sitting and pressure showed similar behavior patterns. No significant differences between both treatment groups were encountered in terms of analgesic efficacy. Incidence of adverse effects was significantly higher in the paracetamol/codeine group (X2: p < 0.05): 11 out of 74 patients; three patients had to discontinue treatment. In the lysine clonixinate group four out of 77 patients showed side effects but these did not require treatment discontinuation.

[Analgesic-antispasmodic effect and safety of lysine clonixinate and L-hyoscinbutylbromide in the treatment of dysmenorrhea]. / Efecto analgésico antiespasmódico y seguridad del clonixinato de lisina y bromuro de L-butilhioscina en el tratamiento oral de la dismenorrea.

The purpose of this longitudinal open but not comparative study was to confirm the safety and efficacy of Lysine clonixinate (125 mg) and hyoscinbutylbromide (10 mg) capsules, during a period of observation of there menstrual cycles on 30 women with uterine dysfunction due to primary or secondary dysmenorrhea. The time of evolution for primary dysmenorrhea was of 4.46 years, and for secondary was of 1.77 years. Some associated manifestations of dysmenorrhea were: nausea (92%), vomit (92%), general pain (82.1%), abdominal pain (85.7%) and headache (46.4%). Regarding to the menstrual pain intensity, at first was highly severe in 10.7% severe in 42.9%, and moderate in 46.4%. At the end of the study, only 1 of 28 patients showed menstrual pain of moderate intensity. Only three adverse effects of light intensity were found without needing treatment, related to the manifestations of gastralgia and sleepiness. The association of a spasmolytic analgesic (Lysine clonixinate and hyoscinbutylbromide bromide) on the treatment for primary or secondary dysmenorrhea, reduces and prevents the menstrual pain (colic) as well as the associated manifestations with few spasmolytic association is efficacy and safety.

Lysine clonixinate vs. paracetamol/codeine in postepisiotomy pain.

This study was conducted to compare the analgesic action of Lysine Clonixinate (LC) vs Paracetamol/Codeine association (PC) in the treatment of postepisiotomy pain in primiparae women: 131 primiparous patients with moderate-to-severe postepisiotomy pain were enrolled in a double blind dummy design study and randomly allocated to either treatment with fixed doses of LC 125 mg or Paracetamol 500 mg+Codeine 30 mg 6 qh during 24 hours. Intensity of spontaneous pain and pain on walking was assessed according to a visual analog scale (VAS) and patient's assessment before receiving treatment and after 1, 2, 6 and 24 hours. Intensity of spontaneous pain was reduced in 24 hours from 4.28 +/- 2.11 to 1.73 +/- 1.46 (P < 0.0001) in the LC group and from 4.78 +/- 2.08 to 1.90 +/- 1.72 in the PC-treated group (p < 0.0001); with no significant differences between treatments. 54% of the patients treated with LC and 55% of those receiving PC showed onset of analgesic action 30 minutes following dose administration. Patient's final global assessment revealed that 95% of LC-treated patients and 96% of the PC group showed total or partial pain relief during the first treatment day. No sleep disturbances were seen during the night in 75% of patients. Only one patient receiving LC showed nausea not requiring treatment discontinuation. It is concluded that both treatments are equally effective to relieve moderate-to-severe postepisiotomy pain.

Efecto analgésico antiespasmódico y seguridad del clonixinato de lisina y bromuro de L-Butilhioscina en el tratamiento oral de la dismenorrea / Antispasmodic-analgesic effect and safety of Lysene clonixinate and Butylhioscine broide for dysmenorrhea oral treatment

Fue realizado un estudio clínico longitudinal abierto, no comparativo, en 30 mujeres con diagnóstico de dismenorrea primaria o secundaria a dispositivo intrauterino. El objetivo del estudio fue evaluar la eficacia y seguridad del compuesto terapéutico, Clonixinato de lisina y Bromuro de butihioscina 125 y 10 mg respectivamente, en cápsulas, durante un periodo de observación de tres ciclos menstruales. El tiempo de evolución de la dismenorrea primaria fue de 4.46 años; para la secundaria fue de 1.77 años. A la dismenorrea le acompañaron síntomas asociados como: náusea 92 por ciento, vómito 92 por ciento, malestar general 82.1 por ciento, pesantez abdominales 85.7 por ciento y cefalea 46.4 por ciento. Respecto a la intensidad del dolor menstrual, al inicio fue muy severo en el 10.7 por ciento, severo en 42.9 por ciento y moderado 46.4 por ciento. Al final del estudio sólo una paciente de las 28, presentó dolor menstrual de intensidad moderada. Encontramos sólo tres menciones de efectos secundarios de intensidad leve y que no requirieron tratamiento; que correspondieron a dos menciones de gastralgía y una de somnolencia. La conclusión del estudio es que la asociación analgésica espasmolítica del Clonixinato de lisina y Bromuro de butilhioscina en el tratamiento de la dismenorrea primaria o secundaria, reduce y previene el dolor menstrual, así como las manifestaciones asociadas con pocos efectos secundarios. Esta asociación analgésica espasmolítica, es eficaz y segura

Lysine clonixinate vs. paracetamol / codeine in postepisiotomy pain

This study conducted to compare the analgesic action of Lysine Clonixinate (LC) vs Paracetamol/Codeine association (PC) in the treatment of postepisiotomy pain in primiparae women: 131 primiparous patients with moderate-to-severe postepisiotomy pain were enrolled in a double blind dummy design study and randomly allocated to either treatment with fixed doses of LC 125 mg or Paracetamol 500 mg+Codeine 30 mg 6 qh during 24 hours. Intensity of spontaneous pain and pain on walking was assessed according to a visual analog scale (VAS) and patientÝs assessment before receiving treatment and after 1, 2, 6 and 24 hours. Intensity of spontaneous pain was reduced in 24 hours from 4.28+2.11 to 1.73+1.46 (P<0.0001) in the LC group and from 4.78+2.08 to 1.90+1.72 in the PC- treated group (p<0.0001); with no significant differences between treatments. 54 percent of the patients treated with LC and 55 percent of those receiving PC showed onset of analgesic action 30 minutes following dose administration. PatientÝs final global assessment revealed that 95 percent of LC-treated patients and 96 percent of the PC group showed total or partial pain relief during the first treatment day. No sleep disturbances were seen during the night in 75 percent of patients. Only one patient reveiving LC showed nausea not requiring treatment discontinuation. It is concluded that both treatments are equally effective to relieve moderate-to-severe postepisiotomy pain.

Lysine clonixinate vs. paracetamol / codeine in postepisiotomy pain

This study conducted to compare the analgesic action of Lysine Clonixinate (LC) vs Paracetamol/Codeine association (PC) in the treatment of postepisiotomy pain in primiparae women: 131 primiparous patients with moderate-to-severe postepisiotomy pain were enrolled in a double blind dummy design study and randomly allocated to either treatment with fixed doses of LC 125 mg or Paracetamol 500 mg+Codeine 30 mg 6 qh during 24 hours. Intensity of spontaneous pain and pain on walking was assessed according to a visual analog scale (VAS) and patientYs assessment before receiving treatment and after 1, 2, 6 and 24 hours. Intensity of spontaneous pain was reduced in 24 hours from 4.28+2.11 to 1.73+1.46 (P<0.0001) in the LC group and from 4.78+2.08 to 1.90+1.72 in the PC- treated group (p<0.0001); with no significant differences between treatments. 54 percent of the patients treated with LC and 55 percent of those receiving PC showed onset of analgesic action 30 minutes following dose administration. PatientYs final global assessment revealed that 95 percent of LC-treated patients and 96 percent of the PC group showed total or partial pain relief during the first treatment day. No sleep disturbances were seen during the night in 75 percent of patients. Only one patient reveiving LC showed nausea not requiring treatment discontinuation. It is concluded that both treatments are equally effective to relieve moderate-to-severe postepisiotomy pain. (AU)

[Morphine infusion for postoperative pain management in patients who have undergone upper abdominal surgery]. / Infusión de morfina para el manejo del dolor postoperatorio en pacientes sometidos a cirugía abdominal alta.

We compared the efficacy and side effects of postoperative continuous infusions versus intermittent intravenous on-demand morphine, with or without the addition of clonixin. Eighty five healthy patients, aged 18 to 65 years, scheduled for elective cholecystectomy, were prospectively randomized: Group 1 (n = 22) received morphine 2.5 mg i.v. on-demand; group 2 (n = 22) received a clonixin 400 mg/day i.v. infusion; group 3 (n = 19) a morphine 0.4 mg/kg/day i.v. infusion; and group 4 (n = 22) received a clonixin 400 mg/day plus a morphine 0.4 mg/kg/day i.v. infusion. Groups 2, 3 and 4 also received, on-demand, 2.5 mg i.v. bolus doses of morphine. A blind observer recorder analogue and descriptive pain scores, respiratory rates and side-effects for 72 hours postoperatively. Groups with morphine infusions had less overall pain scores for the first day when compared with intermittent dosing (p < 0.05); these groups also had less pain during the night (p = 0.0016) and required less additional morphine (p < 0.0001). Side-effects were similar and no cases of heavy sedation or respiratory depression were observed. We conclude that a morphine 0.4 mg/kg/day infusion is a safe and effective alternative to on demand dosing in healthy patients after elective cholecystectomy, achieving better analgesia without increasing side-effects. Clonixin 400 mg/day seems to add no significant benefits.

Lysine clonixinate in minor dental surgery: double-blind randomized parallel study versus paracetamol.

Lysine clonixinate (LC), an effective and well tolerated non-morphinic analgesic whose mechanism of action is basically due to the inhibition of cyclo-oxygenase, was assessed with a double-blind randomized dummy design versus paracetamol (P) on 200 patients suffering from pain after minor dental surgery. Patients received according to their needs 1 or 2 tablets of 125 mg lysine clonixinate or 500 mg paracetamol every 8 h during 48 h or until pain relief. Both groups, each composed of 100 patients, were comparable in terms of demographic conditions (t test), initial symptoms (chi-square test), characteristics of the extracted dental pieces, surgical complications and wound treatment (chi-square test). Pain intensity scores and daily average intake of tablets (3.4/day) documented in the patients' diary revealed no statistically significant differences between the two treatments (chi-square test). It was found that spontaneous pain measured using a visual analogue scale (VAS) decreased significantly in both treatment groups at the 24-h control examination. The following values were observed in the LC group: baseline 4.38 +/- 1.7; 24-h * 1.20 +/- 1.4; 48-h * 0.36 +/- 1.2. In the P group the values were: baseline 4.28 +/- 1.6; 24-h * 1.11 +/- 1.4; 48-h * 0.30 +/- 0.7 (*p < 0.05). Other variables like facial swelling and night pain, evaluated on a score from 0 to 4 and symptom presence or absence respectively, showed a similar response.(ABSTRACT TRUNCATED AT 250 WORDS)