EFFICACY AN ORAL FIXED-DOSE COMBINATION OF PARACETAMOL AND TRAMADOL IN SURGICAL AND TRAUMATOLOGY PRACTICE

DOI: https://doi.org/10.29296/25877305-2021-11-14
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Issue: 
11
Year: 
2021

A. Mymrina(1, 3), Candidate of Pharmaceutical Sciences; S. Kan(1), MD; I. Mugatasimov(2),
Candidate of Medical Sciences; V. Shapkina(2), Candidate of Medical Sciences; E. Aksenov(2); Associate
Professor A. Povetyev(2); I. Golubeva(3), Candidate of Biological Sciences (1)Novokuznesk State Institute
for Postgraduate Training of Physicians, Branch, Russian Medical Academy of Continuing Professional
Education, Novokuznesk (2)G.P. Kurbatov Novokuznetsk City Hospital One (3)AO «Organika», Novokuznetsk

Objective: to compare the efficacy, tolerability, and safety of the combined drug Paracetamol 325 mg + Tramadol 37.5 mg produced by the AO «Organika» (Novokuznetsk) and 2 ml of Tramadol 50 mg/ml solution for injection in the postoperative period in adult patients with pain syndrome (PS) of moderate and high intensities. Subjects and methods. The investigation enrolled 115 patients over 18 years of age with PS in the early postoperative period. The patients were divided into groups according to the results of the postoperative history: the presence or absence of dyspeptic disorders. A control group included 55 patients with symptoms of nausea and vomiting; they were prescribed injectable Tramadol 50 mg/ml solution for injections. A study group consisted of 60 patients without dyspeptic disorders who were prescribed the combined drug Paracetamol 325 mg + Tramadol 37.5 mg film-coated tablets. Its daily and single doses were individually adjusted according to the instruction. The efficiency of analgesic therapy was evaluated using a visual analogue scale (VAS) for pain intensity. Results and discussion. The duration of anesthesia varied from 1 to 20 days (an average of 4.32 days) according to pathology. The groups did not statistically differ in gender, age, and concomitant pathology. The patients’ mean age was 48.33 years (50.28 years in the study group and 46.2 years in the control group). Effective pain relief was achieved in 100% of cases; after taking the anesthetic, the VAS scores varied from 0 to 1 in both groups. There were no statistically significant differences in the results of analgesic therapy between the groups before and after taking the painkiller. This study indicated no adverse reactions from the use of tramadol in patients taking the combined drug (Paracetamol + Tramadol). It should be noted that the use of the combined drug for pathology of trauma can significantly reduce the daily dose of tramadol, which contributes to the increased safety of patient management in the postoperative period. Conclusion. The fixed combination Paracetamol 325 mg + Tramadol 37.5 mg produced by the AO «Organika» (Novokuznetsk) allows for the effective and safe therapy of moderate and high PS intensity and is an alternative to the invasive dosage forms of anesthetic drugs, while significantly reducing the manifestations of their side effects.
Keywords: 
surgery
postoperative period
pain syndrome
tramadol
combined drug Paracetamol + Tramadol

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