INTRODUCTION

Therapy of postoperative pain is still one of the important areas of work of the anesthesiologist. Over 4/5 of surgical patients require intensive pain management after surgery. Goal is to evaluate the applicability of Tafalgin in the postoperative pain management

MATERIAL AND METHODS

A single-blind, multicentre, comparative, randomized study was conducted at seven research centers in Moscow, St. Petersburg, Smolensk, Penza, and Ryazan. 250 patients with postoperative pain after moderately traumatic elective surgery and assessment of inclusion and non-inclusion criteria were included. Pain relief was provided intravenous administration of 1000 mg of Paracetamol after the end of the surgery to all patients, then in group 1, patients were prescribed Tafalgin at a dose of 4 mg subcutaneously 3 times a day, in group 2, the pain therapy regimen consisted of placebo injection subcutaneously, and after 8 hours they administered Dexketoprofen at a dose of 50 mg intramuscularly 3 times a day. Group 3 patients received Trimeperidine at a dose of 20 mg subcutaneously 3 times a day. Paracetamol was administered every 8 hours at 1000 mg, while the maximum daily dose reached 3000 mg. TOTPAR score [0—6] was selected as the primary endpoint. As secondary endpoints, the pain intensity at rest and in moving, the assessment of the effectiveness of therapy by the researcher and the assessment of adverse events from the use of Tafalgin were evaluated.

RESULTS

Pain intensity at various time points was, on average, statistically significantly lower in the Tafalgin group compared to placebo (p<0.0001), thus showing the superiority of the analgesic effect of Tafalgin over placebo. When comparing the effectiveness of Tafalgin and Trimeperidine, the difference in the mean values of TOTPAR 0—6] was –0.06 with the lower limit of 95% CI equal to –2.39, which proves approximately equal the analgesic potential of the studied drugs. The evaluation of the effectiveness of analgesic therapy by the research physician was significantly higher in the Tafalgin and Trimeperidine groups compared to the placebo group. The patients with reported cases of adverse events during the study was 4.4% (11/250). At the same time, the severity of adverse events in all groups was mild and no changes in the pain therapy regimen due to the development of adverse events were recorded during the study.

CONCLUSIONS

1) According to the results of the clinical study, the hypotheses of the superiority of therapy with Tafalgin over placebo and non-inferiority of efficacy in comparison with the full opioid receptor agonist Trimeperidine in patients with postoperative pain were proven. 2) The results of the assessment of safety parameters indicate a favorable safety profile of the drug Tafalgin.