Skip navigation
Acute Pain | Chronic Pain | General

Oral rofecoxib in postoperative pain

Clinical bottom line

Rofecoxib is an effective analgesic in acute pain. The NNT for rofecoxib 50 mg for at least 50% pain relief over six hours was 2.3 (95% confidence interval 2.0 to 2.6). The weighted mean remedication time was 1.9 hours for placebo (126 patients), 7.4 hours for ibuprofen 400 mg (97 patients) and 13.6 hours for rofecoxib 50 mg (322 patients).

Rofecoxib is a Cox-2 inhibitor that has been shown to be an effective analgesic in osteoarthritis and rheumatoid arthritis at single daily doses of 12.5 or 25 mg. At these (and higher) doses it has also been shown to reduce the incidence of gastrointestinal bleeding on chronic use for arthritis compared with NSAIDs, in both a systematic review and a separate large randomised trial.


J Barden, JE Edwards, HJ McQuay, RA Moore. Rofecoxib for acute postoperative pain: a quantitative systematic review. BMC Anesthesiology 2002, 2:4 ( )

Inclusion criteria were single oral dose, randomised, placebo-controlled, double-blind trials of rofecoxib in acute postoperative pain with sufficient data to calculate the area under the curve for pain relief (TOTPAR). Baseline pain was moderate to severe. The 6 hour TOTPAR was calculated for each patient, and the data were converted to the percent of maximum total pain relief from categorical pain scales (%maxTOTPAR), and then to dichotomous information to generate a number-needed-to-treat for at least 50% pain relief. Relative benefit was calculated to provide an assessment of how much more likely an individual given a particular treatment is to have at least 50% pain relief than someone given no treatment. Adverse effects frequency data were used to calculate numbers-needed-to-harm and relative risk.


There were five placebo-controlled trials that also had active comparators. All showed statistical benefit of rofecoxib 50 mg over placebo (Figure 1). Overall 252/464 patients (54%) given rofecoxib 50 mg had at least 50% maxTOTPAR over six hours, compared with 24/211 patients (11%) with placebo. The NNT for one patient to have at least half pain relief over six hours was 2.3 (2.0 to 2.6).

Figure 1: Trials comparing rofecoxib 50 mg with placebo in acute postoperative pain

Median time to remedication was given in three studies allowing calculation of a weighted mean. For placebo the weighted mean time to remedication from 126 patients in three trials was 1.9 hours. For rofecoxib 50 mg the weighted mean time to remedication from 322 patients in three trials was 13.6 hours. For ibuprofen 400 mg the weighted mean time to remedication from 97 patients in two trials was 7.4 hours (Figure 2).

Figure 2: Weighted mean time to remedication

Adverse events

Two trials reported the proportion of patients having any adverse event. An adverse event was reported by 33% of patients on placebo and 28% of those on rofecoxib 50 mg. There was limited evidence based on few events that nausea and vomiting were slightly less likely with rofecoxib.


Rofecoxib was an effective analgesic in single oral doses about twice those given for arthritis. Good analgesia over six hours may be accompanied by good long-duration analgesia, but the evidence on this is not yet conclusive.