A randomised clinical trail comparing the analgesic and anxiolytic efficacy and tolerability of Stilpane® and Tramacet® after third molar extraction

Abstract

BACKGROUND : successful treatment of moderate to severe acute pain often necessitates several analgesics that target different sites of the nociceptive pathway. Fixed-dose combination analgesics facilitate a reduction in dose of individual components, increased compliance and strong-opioid sparing. The aim of this study was to compare the analgesic and anxiolytic efficacy and tolerability of two widely prescribed combination analgesics, Stilpane® (paracetamol/codeine/meprobamate) and Tramacet® (paracetamol/tramadol). METHODS : A prospective randomised parallel group phase IV clinical trial was conducted in 100 patients experiencing moderate to severe pain after third molar extraction at the Oral and Dental Hospital, University of Pretoria. Pain intensity and pain relief were assessed using Likert and visual analogue scales. Medication efficacy, time to perceptible pain relief and meaningful pain relief were also assessed. Primary variables included the Pain Intensity Difference (PID) between baseline and scheduled visits, and hourly pain relief (PAR). The Summed Pain Intensity Difference (SPID), Sum of hourly PAR, hourly PAR, hourly PIDs from baseline (SPRID) and Total Pain Relief (TOTPAR) were calculated according to standard methods. Beck Anxiety Questionnaire assessed anxiety. Tolerability was assessed chiefly by the reporting of adverse events. RESULTS : Stilpane® and Tramacet® were equally effective at relieving moderate to severe acute pain. No differences in anxiolytic efficacy were found between the two treatment arms and differences in tolerability failed to reach statistical significance. CONCLUSIONS : Despite their distinctive compositions and mechanisms of action, Stilpane® and Tramacet® are equally effective and well-tolerated combination analgesics in patients experiencing moderate to severe acute pain.