Background: Nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely used for pain relief in patients with renal colic. Dexketoprofen trometamol is an NSAID that has demonstrated good analgesic efficacy and a good safety profile after oral administration in different models of acute and chronic pain.
Objective: To assess the analgesic efficacy and safety of single intramuscular doses of dexketoprofen trometamol (25 and 50mg) compared with dipyrone (2g) in moderate to severe pain due to renal colic.
Study design: Multicentre, randomised, double-blind, parallel-group study.
Patients: PATIENTS of both sexes aged 18-70 years with a diagnosis of renal colic were eligible for randomisation if they presented with at least moderate pain as assessed by visual analogue scale (VAS) scoring ≥40mm on a scale of 100mm immediately before study drug administration.
Methods: Assessment of analgesic efficacy was done using standard pain intensity and pain relief scales. Total scores from baseline to 6 hours after study drug administration were calculated for the sum of pain intensity differences relative to baseline (SPID), sum of analogue pain intensity differences relative to baseline (SAPID) and total pain relief scores (TOTPAR) as primary efficacy endpoints. Secondary efficacy and safety variables were also analysed.
Results: A total of 333 patients (dexketoprofen 25mg, n = 112; dexketoprofen 50mg, n = 113; dipyrone 2g, n = 108) were included in the study. No significant differences were found between the treatment groups with regard to SPID (p = 0.797), SAPID (p = 0.852) and TOTPAR (p = 0.716). The time-effect course for pain intensity differences and pain relief showed significantly (p < 0.05) higher values for both doses of dexketoprofen trometamol compared with dipyrone during the first hour after treatment administration. More than 90% of the patients in all three groups achieved pain relief of at least 50% as compared with baseline. Similarly, over 70% of the patients in all three groups considered the received treatment as excellent or good in the overall assessment of efficacy at the end of the study. No dose-effect relationship was observed in this pain model between both doses of dexketoprofen trometamol. All three treatments were well tolerated, showing mostly mild to moderate adverse events.
Conclusion: Dexketoprofen trometamol is a good analgesic for the treatment of moderate to severe pain due to renal colic, with a good safety profile and an efficacy comparable to that of dipyrone. The significantly greater effect of dexketoprofen trometamol early after administration suggests a faster onset of action, which can be of paramount importance in this condition.