Clinical tolerability of perioperative tenoxicam in 1001 patients - a prospective, controlled, double-blind, multi-centre study

We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, prospective, randomised study. Patients undergoing surgery, screened for contraindications to non-steroidal anti-inflammatory drug, received tenoxicarn (n = 750) on 2843 days or placebo (n = 25 1) on 988 days, in courses of 1-12 days. There was no increase in the overall incidence of side effects with tenoxicam (33 vs 38% with placebo: P = 0.15), or in major side effects (3.9 vs 2.0% with placebo: P = 0.11). Of major side effects possibly or probably related to tenoxicam (2.1 vs 1.2% with placebo: P = 0.26), all but one involved post-operative surgical site bleeding. However, in the subgroup of patients undergoing otorhinolaryngology surgery, surgical site bleeding occurred in 18 of 171 (10.5%) patients on tenoxicam and one of 57 (1.8%) on placebo (P = 0.026); of these, nine in the tenoxicam group and 0 in the placebo were classified as major (P = 0.07). One patient on tenoxicarn experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicarn is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than I in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding. (C) 2004 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.