National Conference of the Italian Association for the Study of Pain
Vol. 3 No. s2 (2026): 49th National Conference of the Italian Association for the Study of Pain
https://doi.org/10.4081/ahr.2026.279

EFFICACY AND SAFETY OF THE FIXED DOSE COMBINATION OF ACETAMINOPHEN AND TRAMADOL IN THE MANAGEMENT AND TREATMENT OF PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS

D. Scaturro1, S. Tomasello2, M. Mangrelli3, D. Trastulli3, R. Piazza3, G. Letizia Mauro1 | 1Department of Precision Medicine in the Medical, Surgical and Critical Care Area, University of Palermo, Italy; 2Palermo Provincial Health Authority, Palermo, Italy; 3Italfarmaco SpA, Medical Affairs Department, Milan, Italy

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Received: 21 September 2026
Published: 21 September 2026
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Background. Current management and treatment of pain involves the administration of non-opioid and opioid analgesic agents (1), adjuvant analgesics and corticosteroids (2), however, a non-complete resolution of symptoms and treatment-emergent adverse events represent a major unmet clinical need.
Method. We performed a systematic literature review and meta-analysis, aiming at evaluating the efficacy and safety of tramadol and acetaminophen combination compared with tramadol alone, NSAIDs, and strong opioids.
Results. Our analysis revealed that tramadol and acetaminophen is more effective than tramadol alone in the management of postoperative pain with a better safety profile. In particular, a 75/650 mg fixed-dose formulation compared with tramadol alone may represent an optimal balance between efficacy and tolerability. Tramadol and acetaminophen combination resulted more efficient in comparison with NSAIDs both in acute and chronic pain, and a comparable safety profile. Importantly, the efficacy and safety of tramadol and acetaminophen resulted comparable with strong opioids.
Conclusion. Our analysis shows that the combination of tramadol and acetaminophen in the management of pain has the beneficial property of alleviating pain and causing less adverse events in different settings, potentially alleviating patients from treatment load and enhancing their quality of life, and ultimately treatment adherence. These findings position tramadol and acetaminophen fixed-dose combinations as a potential first-line pharmacological strategy for moderate-to-severe pain.

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1. Queremel Milani DA, Davis DD. Pain Management Medications. 2023 Jul 3. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan. PMID: 32809527.

2. Alorfi NM. Pharmacological Methods of Pain Management: Narrative Review of Medication Used. Int J Gen Med. 2023;16:3247-3256. doi: 10.2147/IJGM.S419239.

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1.
EFFICACY AND SAFETY OF THE FIXED DOSE COMBINATION OF ACETAMINOPHEN AND TRAMADOL IN THE MANAGEMENT AND TREATMENT OF PAIN: A SYSTEMATIC REVIEW AND META-ANALYSIS: D. Scaturro1, S. Tomasello2, M. Mangrelli3, D. Trastulli3, R. Piazza3, G. Letizia Mauro1 | 1Department of Precision Medicine in the Medical, Surgical and Critical Care Area, University of Palermo, Italy; 2Palermo Provincial Health Authority, Palermo, Italy; 3Italfarmaco SpA, Medical Affairs Department, Milan, Italy. Adv Health Res [Internet]. 2026 Sep. 21 [cited 2026 Sep. 30];3(s2). Available from: https://www.ahr-journal.org/site/article/view/279
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