PMID- 15363875
OWN - NLM
STAT- MEDLINE
DCOM- 20041216
LR  - 20210112
IS  - 0304-3959 (Print)
IS  - 0304-3959 (Linking)
VI  - 111
IP  - 3
DP  - 2004 Oct
TI  - Clinical tolerability of perioperative tenoxicam in 1001 patients--a prospective, 
      controlled, double-blind, multi-centre study.
PG  - 313-322
LID - 10.1016/j.pain.2004.07.013 [doi]
AB  - 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.
FAU - Merry, Alan F
AU  - Merry AF
AD  - 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.
FAU - Webster, Craig S
AU  - Webster CS
FAU - Holland, Robin L
AU  - Holland RL
FAU - Middleton, Neil G
AU  - Middleton NG
FAU - Schug, Stephan A
AU  - Schug SA
FAU - James, Margaret
AU  - James M
FAU - McGrath, Ken A
AU  - McGrath KA
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Pain
JT  - Pain
JID - 7508686
RN  - 13T4O6VMAM (Piroxicam)
RN  - Z1R9N0A399 (tenoxicam)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Confidence Intervals
MH  - Double-Blind Method
MH  - Female
MH  - Gastrointestinal Diseases/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Perioperative Care/*methods/statistics & numerical data
MH  - Piroxicam/*adverse effects/*analogs & derivatives/therapeutic use
MH  - Prospective Studies
EDAT- 2004/09/15 05:00
MHDA- 2004/12/17 09:00
CRDT- 2004/09/15 05:00
PHST- 2004/01/27 00:00 [received]
PHST- 2004/07/05 00:00 [revised]
PHST- 2004/07/12 00:00 [accepted]
PHST- 2004/09/15 05:00 [pubmed]
PHST- 2004/12/17 09:00 [medline]
PHST- 2004/09/15 05:00 [entrez]
AID - 00006396-200410000-00013 [pii]
AID - 10.1016/j.pain.2004.07.013 [doi]
PST - ppublish
SO  - Pain. 2004 Oct;111(3):313-322. doi: 10.1016/j.pain.2004.07.013.