Acute pain management: the role of multimodal analgesia with a focus on dexketoprofen and tramadol hydrochloride fixed-dose combination in acute low back pain

Giustino Varrassi, Giacomo Farì, Marco Mercieri, Matteo Luigi Giuseppe Leoni. Acute pain management: the role of multimodal analgesia with a focus on dexketoprofen and tramadol hydrochloride fixed-dose combination in acute low back pain. Signa Vitae. 2025. 21(6);1-10. DOI: 10.22514/sv.2025.078

Abstract

Acute pain, such as moderate to severe low back pain, significantly impacts quality of life and is a leading cause of disability. Traditional pain management, often reliant on opioids, is facing scrutiny due to concerns about side effects, dependency and misuse. Multimodal analgesia, which combines different analgesics targeting various pain pathways, has emerged as a safer alternative to minimize opioid use. This narrative review focuses on the combination of dexketoprofen trometamol (a nonsteroidal anti-inflammatory drug) and tramadol hydrochloride (a centrally acting analgesic), which together target both peripheral and central pain mechanisms. Particular attention is given to the pharmacological properties of these agents and the results of key clinical trials, especially the Dexketoprofen TrometAmol aNd Tramadol HydrochloridE (DANTE) study. The DANTE study, a Phase IV clinical trial, demonstrated that the fixed-dose combination of dexketoprofen and tramadol significantly reduced pain intensity and improved functional outcomes in patients with acute low back pain. Furthermore, the combination showed a favorable safety profile comparable to that of single-agent treatments, with mild and manageable adverse events. This evidence suggests that the dexketoprofen–tramadol combination offers a more effective and well-tolerated alternative to traditional pain management strategies. By targeting multiple pain pathways simultaneously, this multimodal approach can enhance analgesic efficacy while reducing opioid reliance, representing a promising advance in the management of acute pain.