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 tenoxicam (n=750) on 2843 days or placebo (n=251) 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 tenoxicam experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicam is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than 1 in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding.
Merry
Alan F
AF
Department of Anaesthesiology, School of Medicine, University of Auckland, Private Bag 92-019, Auckland, New Zealand Green Lane Department of Anaesthesia, Auckland City Hospital, Auckland, New Zealand Department of Intensive Care, Blacktown Hospital, Sydney, NSW, Australia Department of Pharmacology, University of Western Australia, and Royal Perth Hospital, Perth, WA, Australia Faculty of Health, Auckland University of Technology, Auckland, New Zealand.
Webster
Craig S
CS
Holland
Robin L
RL
Middleton
Neil G
NG
Schug
Stephan A
SA
James
Margaret
M
McGrath
Ken A
KA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016001:Confidence Intervals; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D019990:Perioperative Care / Q000379:methods* / Q000706:statistics & numerical data; D010894:Piroxicam / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011446:Prospective Studies
D010894:Piroxicam; C032801:tenoxicam