Philip L Møller1, Sven E Nørholt. 1. Department of Oral and Maxillofacial Surgery, Aarhus University Hospital, Aarhus, Denmark.
Abstract
OBJECTIVE: The aim of this study was to evaluate the analgesic efficacy and time to onset of effect of the lornoxicam quick-release (LNX-QR) tablet compared with the standard-release tablet (LNX-ST). METHODS: In this randomized, double-blind, single-dose trial, 200 patients with moderate pain after surgical removal of an impacted third molar were randomized to treatment with an LNX-QR 8 mg tablet (80 patients), an LNX-ST 8 mg tablet (80 patients) or placebo (40 patients). Pain intensity (PI) and pain relief (PAR) were assessed (numerical and verbal rating scales) for 6 hours, and time to onset of PAR was recorded. The cumulated sum of PI differences (SPID) and PAR (TOTPAR) were calculated. Tolerability was evaluated by occurrence of adverse events. RESULTS: Kaplan-Meier analysis of time to onset of analgesic efficacy demonstrated a significantly faster onset with LNX-QR than placebo or LNX-ST (p < 0.0001). Median time of onset was 32 minutes (range 29-37) for LNX-QR and 46 minutes (range 37-59) for LNX-ST. The analgesic efficacy of LNX-QR and LNX-ST were superior to that of placebo, whereas paired comparisons of TOTPAR and SPID showed LNX-QR to be superior to LNX-ST (p < 0.05). CONCLUSION:LNX-QR provided a faster onset and superior analgesic effect against pain following third molar surgery than LNX-ST.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate the analgesic efficacy and time to onset of effect of the lornoxicam quick-release (LNX-QR) tablet compared with the standard-release tablet (LNX-ST). METHODS: In this randomized, double-blind, single-dose trial, 200 patients with moderate pain after surgical removal of an impacted third molar were randomized to treatment with an LNX-QR 8 mg tablet (80 patients), an LNX-ST 8 mg tablet (80 patients) or placebo (40 patients). Pain intensity (PI) and pain relief (PAR) were assessed (numerical and verbal rating scales) for 6 hours, and time to onset of PAR was recorded. The cumulated sum of PI differences (SPID) and PAR (TOTPAR) were calculated. Tolerability was evaluated by occurrence of adverse events. RESULTS: Kaplan-Meier analysis of time to onset of analgesic efficacy demonstrated a significantly faster onset with LNX-QR than placebo or LNX-ST (p < 0.0001). Median time of onset was 32 minutes (range 29-37) for LNX-QR and 46 minutes (range 37-59) for LNX-ST. The analgesic efficacy of LNX-QR and LNX-ST were superior to that of placebo, whereas paired comparisons of TOTPAR and SPID showed LNX-QR to be superior to LNX-ST (p < 0.05). CONCLUSION:LNX-QR provided a faster onset and superior analgesic effect against pain following third molar surgery than LNX-ST.
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