OBJECTIVE: The objective of this 6-hour study was to compare rate of pain relief, analgesic efficacy and tolerability of a novel ibuprofen formulation, ibuprofen sodium dihydrate, with that of ibuprofen acid in subjects with postoperative dental pain. MATERIAL AND METHODS: The test formulation of ibuprofen sodium dihydrate (256 mg sodium salt) and the reference product both contain 200 mg ibuprofen. Subjects with moderate-to-severe pain after extraction of third molars were randomized to receive two tablets of either ibuprofen sodium dihydrate (198 subjects) or ibuprofen (198 subjects) in this double-blind, multicenter trial. Pain was measured using traditional descriptor scales and onset of analgesia assessed using the stop-watch method. RESULTS:Median time to substantial pain relief occurred 14 minutes earlier in the ibuprofen sodium dihydrate group (p < 0.001). The first sign of pain relief, an increase in relief and time until the pain was half gone occurred significantly earlier and faster in the ibuprofen sodium dihydrate-treated patients (p < 0.02-0.00003). Corresponding numbers needed to treat were in the range 11. Reduction in pain intensity was evident within 5 minutes (p < 0.01) in the ibuprofen sodium dihydrate group compared to 15 minutes in the ibuprofen group. Pain intensity was reduced to half after 30 and 57 minutes in the ibuprofen sodium dihydrate and ibuprofen groups, respectively (p < 0.025). The overall analgesic efficacy in terms of summed pain intensity differences (SPID), total pain relief (TOTPAR) and remedication times in the two groups were similar. Both treatments were well tolerated and no serious events occurred. CONCLUSION:Ibuprofen sodium dihydrate provides faster and more efficacious pain relief during the first hour after intake when compared to a conventional ibuprofen acid formulation. The tolerability profiles are similar.
RCT Entities:
OBJECTIVE: The objective of this 6-hour study was to compare rate of pain relief, analgesic efficacy and tolerability of a novel ibuprofen formulation, ibuprofen sodium dihydrate, with that of ibuprofen acid in subjects with postoperative dental pain. MATERIAL AND METHODS: The test formulation of ibuprofen sodium dihydrate (256 mg sodium salt) and the reference product both contain 200 mg ibuprofen. Subjects with moderate-to-severe pain after extraction of third molars were randomized to receive two tablets of either ibuprofen sodium dihydrate (198 subjects) or ibuprofen (198 subjects) in this double-blind, multicenter trial. Pain was measured using traditional descriptor scales and onset of analgesia assessed using the stop-watch method. RESULTS: Median time to substantial pain relief occurred 14 minutes earlier in the ibuprofen sodium dihydrate group (p < 0.001). The first sign of pain relief, an increase in relief and time until the pain was half gone occurred significantly earlier and faster in the ibuprofen sodium dihydrate-treated patients (p < 0.02-0.00003). Corresponding numbers needed to treat were in the range 11. Reduction in pain intensity was evident within 5 minutes (p < 0.01) in the ibuprofen sodium dihydrate group compared to 15 minutes in the ibuprofen group. Pain intensity was reduced to half after 30 and 57 minutes in the ibuprofen sodium dihydrate and ibuprofen groups, respectively (p < 0.025). The overall analgesic efficacy in terms of summed pain intensity differences (SPID), total pain relief (TOTPAR) and remedication times in the two groups were similar. Both treatments were well tolerated and no serious events occurred. CONCLUSION:Ibuprofen sodium dihydrate provides faster and more efficacious pain relief during the first hour after intake when compared to a conventional ibuprofen acid formulation. The tolerability profiles are similar.