BACKGROUND: Individual patient meta-analysis to determine the
analgesic efficacy and adverse effects of single-dose
rofecoxib in
acute postoperative pain. METHODS: Individual patient information was available from 14 trials; 13 in dental and one in
postsurgical pain. For each patient the percentage of maximum possible
pain relief (%maxTOTPAR) was determined at different time points. The proportion of patients with at least 50% maxTOTPAR, and number-needed-to-treat (NNT) for at least 50% maxTOTPAR, were then calculated, with time when 50% of patients had remedicated (TTR50) and number-needed-to-harm (NNH) for adverse effects. RESULTS: In dental
pain, for
rofecoxib 50 mg (1330 patients) compared with placebo (570 patients) the NNT was 1.9 (95% confidence interval 1.8 to 2.1) for six hours, 2.0 (1.8 to 2.1) at eight, 2.4 (2.2 to 2.6) at 12, and 2.8 (2.5 to 3.1) at 24 hours. The TTR50 was 15.5 hours. Adverse effects were uncommon, though post-extraction alveolitis (
dry socket) occurred more often with
rofecoxib 50 mg than with placebo, NNH 24 (14 to 80). For
postsurgical pain in one trial (163 patients), the NNT for
rofecoxib 50 mg for six hours was 3.9 (2.6 to 7.8), the TTR50 was 5.8 hours, and multiple-dose adverse effects over five days occurred at similar rates with
rofecoxib 50 mg and placebo. CONCLUSIONS: Single-dose
rofecoxib 50 mg is an effective treatment with long-lasting
analgesia and few adverse effects in dental
pain. More information is required to confirm efficacy in
postsurgical pain.