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Prospects and possibilities of using a fixed combination of a solid dosage form of paracetamol and tramadol in traumatology (postoperative period)

DOI: https://doi.org/10.29296/25877305-2021-12-13

A. Mymrina(1, 5), Candidate of Pharmaceutical Sciences; Professor L. Geller(2), PharmD; A.
Plaschinsky(3), Candidate of Medical Sciences; V. Grishchenko(4); Associate Professor I. Tueva(5), Candidate
of Pharmaceutical Sciences (1)Novokuznesk State Institute for Postgraduate Training of Physicians, Branch,
Russian Medical Academy of Continuing Professional Education, Novokuznetsk (2)Irkutsk State Medical
University (3)Regional Hospital Fourth, Sochi (4)A.A. Lutsik Novokuznetsk City Clinical Hospital
Twenty-Ninth (5)AO «Organika», Novokuznetsk

Objective: to evaluate the effectiveness of postoperative analgesia with a fixed combination of paracetamol 325 mg + tramadol 37.5 mg in trauma patients over 18 years of age with moderate and high intensity pain syndrome (PS). Subjects and methods. The study included 60 traumatological patients in the early postoperative period with PS aged over 18 years. Postoperative anesthesia was carried out from the first day with a fixed combination of Paracetamol + Tramadol (Organicа) film-coated tablets 325 mg + 37.5 mg. Daily and single doses were selected individually, according to the instructions. The anesthesia regimen varied in taking a fixed combination of paracetamol and tramadol: 1 tablet from 1 to 4 times a day or 2 tablets 4 times a day. Pain assessment before and after anesthesia was carried out according to the visual analog scale (VAS) of pain intensity. Results and discussion. The duration of anesthesia varied from 1 to 5 days depending on the pathology and averaged 2.9 days. The groups did not differ statistically by gender, age and concomitant pathology. The male sex prevailed in the trauma departments. The average age of patients was 48.75 years. In 100% of cases, effective anesthesia was observed – according to VAS, the score values after taking the painkiller in three centers varied from 0 to 3. The results of the study showed statistically significant differences in the score values on the VAS scale before and after taking the painkiller in three centers. The average score on the pain scale VAS before taking the painkiller was 6.400 in 1 center, 6.440 in 2 center and 6.467 in 3 center, after taking the painkiller – 1.650 (p=0.0012), 1.48 (p=0.0004) and 1.333 (p=0.0078), respectively. Side effects when using a fixed combination of paracetamol and tramadol (in the recommended maximum daily dosages of tramadol up to 400 mg): dizziness, nausea, vomiting, were not observed in patients in this study. Hypotension was observed in two patients (3.45% of the sample size) aged over 70 years while taking painkiller, the manifestation of which was stopped by intravenous administration of dexamethasone. Conclusions. The results of the study indicate that the fixed combination of Paracetamol 325 mg + Tramadol 37.5 mg produced by АО «Organica» (Novokuznetsk) allows for effective and safe therapy of moderate and high intensity PS and is an effective alternative to invasive medicinal forms of painkillers, while achieving a significant reduction in the side effects of the active components included in its composition.

postoperative period
pain syndrome
combined drug Paracetamol + Tramadol

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