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Combining Dexketoprofen with Tramadol enhances pain relief in acute lower back pain, offering a synergistic approach that can improve patient outcomes and reduce the need for higher opioid doses.
The latest study published in ‘Pain and Therapy' assessed the efficacy and safety of Dexketoprofen/Tramadol 25/75 mg (DKP/TRAM) to target moderate to severe acute lower back pain (LBP), with or without radiculopathy.
In this multicenter, randomized, double-blind study by Giustino Varrassi and colleagues, 538 patients with moderate to severe acute LBP were assigned to one of four groups: DKP/TRAM 25/75 mg every 8 hours (number of patients=211), Tramadol 100 mg (number of patients=207), placebo-matched DKP/TRAM (number of patients=59), or placebo-matched Tramadol (number of patients=61) in a 4:4:1:1 ratio respectively.
DKP/TRAM demonstrated a higher proportion of patients achieving the primary endpoint, a reduction in the numeric pain rating scale (NRS-PI) score to <4 or a ≥30% pain intensity reduction up to 8 hours after the first dose, although this difference was statistically insignificant. DKP/TRAM showed superior total pain relief over TRAM at 4, 6, and 8 hours. Additionally, DKP/TRAM considerably reduced NRS-PI scores compared to placebo starting at 1 hour, with a numerically lower score maintained throughout 8 hours. Summed pain intensity difference values were also appreciably lower with DKP/TRAM than with TRAM at the specified time points. Overall, DKP/TRAM was well tolerated. DKP/TRAM exhibited superior efficacy over placebo and Tramadol alone in reducing pain despite not meeting the primary endpoint.
Pain Therapy
Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE)
Giustino Varrassi et. al.
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