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[Comparative clinical multicenter study to evaluate analgesic effectiveness of intramuscular etofenamate and diclofenac in patients with post-surgical pain].

OBJECTIVE: The analgesic efficacy of intramuscular etofenamate (1 g/day) and intramuscular diclofenac (75 mg/day) was assessed in post-surgical pain relief during a period of 3 days. MATERIAL AND METHODS: One hundred ten hospitalized patients undergoing elective surgery were evaluated in an open-label, comparative, randomized, parallel-group, multicenter study. Fifty five patients received etofenamate and 55 patients diclofenac, 1 h before surgery. The doses were administered after 24 and 48 h. Baseline evaluations were carried out 30 min after anesthesia recovery and the clinical efficacy variables were assessed at 1, 6, 12, 24, 36, 48, 60 and 72 h. The efficacy variables were Pain Visual-Analogue Scale (VAS), Pain Analogous Verbal Scale (AVERS), and Well-Being Scale. Adverse events were documented. RESULTS: Patients in both groups showed similar values in post-surgical pain relief (VAS, AVERS). According to VAS, etofenamate at 24 h had a better analgesic action than diclofenac even though it was not statistically significant. Both drugs demonstrated to be safe. Patients in both groups reported nausea, vomiting, flatulence, and pain at injection site. CONCLUSIONS: We find that both etofenamate and diclofenac were safe, tolerable, and effective treatments for the relief of post-surgical pain.

Adult↗

[Effect of non-steroid anti-inflammatory agents on components of the kinin system in animals with experimental inflammation].

The influence exerted by a number of non-steroid antiphlogistic agents on the fermentative mechanism responsible for the formation and decomposition of kininines in an inflammation focus and on the permeability of vessels in a skin changed under the effect of exogenous bradykininine was studied. Bradykininine, chigamin, sodium salicylate and mephenaminate are shown to inhibit "in vitro" the kininogenic and intensify the kininase activity of the exudate in rats with turpentine-induced pleuritis, while indometacin affects only the activity of kininogenases. Butadion, chingamin and sodium mephenaminate merely reduce the reactivity of the skin with respect to exogenous bradykininine.

Animals↗

Study on the effect of etofenamate 10% cream in comparison with an oral NSAID in strains and sprains due to sports injuries.

In this 60 patient study of sports traumatology due to football injuries, etofenamate gel proved equally effective as oral naproxen on the overall pain scores (65% none to mild pain for etofenamate versus 86% for naproxen; p greater than 0.05). The global clinical impression results have been rated as good or excellent in 44% in the naproxen group versus 50% in the etofenamate group. The incidence of side effects in the etofenamate group (3%) was lower than in the naproxen group (20%). This study demonstrates that etofenamate gel has equal efficacy as oral NSAIDS but a better side effect profile in sport injuries in football players.

Administration, Topical↗

[Intramuscular etofenamate in the treatment of acute lumbago. Effectiveness and tolerance in comparison with intramuscular diclofenac-Na].

In a controlled multi-center single-blind study, the relative efficacy and tolerance of i.m. injectable preparations of etofenamat(e) and diclofenac sodium were investigated in 96 patients with acute lumbago. Treatment resulted in obvious improvement in function and reduction in pain, no statistical difference being found between the two drugs. In 43% of the patients treated with etofenamat(e) and 27% of those receiving diclofenac, the final medical report indicated very good therapeutic results. Under etofenamat(e) i.m. therapy, no side effects occurred, and in no case did treatment have to be discontinued. Under diclofenac, two patients experienced adverse reactions, one allergic exanthema, and the other itching and a sensation of heat. A further patient experienced no improvement after the first injection and discontinued treatment.

Adolescent↗

[Anti-inflammatory and analgesic activity of etofenamate after intramuscular injection in laboratory animals].

Antiphlogistic and Analgetic Activity of Etofenamate in Laboratory Animals after Intramuscular Administration by injection of an oily solution of 10.5; 15; 19.5 mg etofenamate/kg body weight it was possible to inhibit the development of the carrageenan edema in the rat paw. Even four days after the single i.m. injection of etofenamate (active substance of Rheumon i.m.) the swelling of the rat paw is effectively prevented. By the Randall-Selitto-analgesia test it was possible to demonstrate the fast onset. Already 1 h after the injection of 15 mg/kg the pain threshold is increased to about 60%. Even in this testsystem the prolonged efficacy of oil diluted etofenamate can be found.

Animals↗

Increased euglobulin fibrinolytic potential in women on oral contraceptives low in oestrogen--levels of extrinsic and intrinsic plasminogen activators, prekallikrein, factor XII, and C1-inactivator.

Components of the fibrinolytic system were studied in samples of plasma from 15 normal, young women and from 11 women taking oral contraceptives containing 30 micrograms ethinyl oestradiol and 150 micrograms levo-norgestrel. Fibrinolytic activity of euglobulins precipitated at pH 5.9 was higher than normal in the hormone group, with significant fluctuations related to the cycle. Normal women showed only minor fluctuations. The concentration of C1-inactivator was lower in euglobulins of the hormone group. However, the difference in fibrinolytic activity was retained, when C1-inactivator was inactivated with sodium flufenamate. Fluctuations of the extrinsic (tissue-type) plasminogen activator (t-PA) activity parallelled those of the euglobulin activity. The intrinsic plasminogen activator activity (dextran sulphate precipitated euglobulin) was significantly increased in the hormone group and the cyclic pattern differed from that of the normal group. The increased activity was factor XII-dependent. Plasma prekallikrein did not differ. The factor XII level was increased in the hormone group but this could not explain the increased intrinsic fibrinolytic activity, suggesting an increase in the quantity of an additional factor XII-dependent proactivator.

Adult↗

[Allergic contact dermatitis caused by etofenamate].

We report on 3 cases of contact dermatitis following topical application of etofenamat. Each patient developed positive reactions in patch tests with etofenamat in concentrations of both 10% and 1%. After testing, one patient showed secondary inflammatory reactions at the original site of application. Considering the frequent administration of etofenamat, contact sensitization seems to be relatively rare.

Administration, Topical↗

Etofenamate and transcutaneous electrical nerve stimulation treatment of painful spinal syndromes.

Thirty patients suffering from painful syndromes of the spine were admitted to a randomized controlled clinical trial. They were divided into two groups and treated either with transcutaneous electrical nerve stimulation (TENS), one application every other day, for 20 days or with TENS and an ointment containing etofenamate 10% gel, 3-5 cm daily on the day of TENS therapy, and the same dose twice daily on the other days. The associated therapy achieved, when compared with TENS alone, a statistically significant better outcome. Furthermore a marked improvement of symptoms was observed in a shorter period of time. Therapy was well tolerated and in only four cases mild, self-limiting, skin reactions were observed. On the basis of these results the use of etofenamate and TENS could represent a viable alternative to systemic nonsteroidal antiinflammatory drug therapy.

Back Pain↗

Ketoprofen vs etofenamate in a controlled double-blind study: evidence of topical effectiveness in soft tissue rheumatic pain.

The efficacy and safety of topical application of ketoprofen gel and etofenamate gel were studied in a controlled double-blind clinical trial. Thirty-six patients affected by inflammation of tendons, sheaths and bursae entered the study, and were treated for seven days. The parameters studied were: pain scale, Ritchie index, stiffness, pain on active and passive movement and functional capacity. The results showed that ketoprofen gel and etofenamate gel were able to induce remission of the inflammatory symptoms in soft tissue rheumatic pain. No side-effects were detected in either group.

Adult↗

[Can one increase the analgesic effect of Mobilisin ointment by iontophoresis? Placebo controlled triple cross-over double-blind study].

In a double-blind, three-way crossover trial, with placebo controls on 41 patients with inflammatory rheumatic disorders (mono- or oligoarticular forms), the analgesic action of Mobilisin ointment, with or without iontophoresis, was significantly stronger than after iontophoresis alone or after placebo. Iontophoresis did not potentiate the analgesic properties of Mobilisin. The pain was scored on VAS in intervals 30 min, 1, 2, 4, 6, 8 h after application. The duration of analgesic effect after Mobilisin procedures was 6.5 h on average, which was significantly longer than after iontophoresis alone or after placebo.

Adolescent↗