Influence of Ketoprofen on Drainage Volume After Radical Breast Cancer Surgery: A Prospective Randomized Clinical Trial [ISRCTN06628870]

Objective: To determine the effectiveness of non steroidal inflammatory drug ketoprofen versus placebo in reducing postoperative drainage duration and volume after breast cancer surgery. Materials and Methods: A single-centre prospective, randomized, double blind controlled study of women scheduled to undergo a simple or modified radical mastectomy. Patients were randomized into two groups given placebo or a single dose of 200 mg sustained release ketoprofen. Primary outcome measure was total drain volume; secondary outcomes were mean drainage periods, drained volume on postoperative days 1 and 2 and associated morbidity. A sample size and power calculation was undertaken to demonstrate a reduction of 20% between groups in primary outcome (power 0.80; significance level 0.05). Results: Forty-eight patients were randomized to the ketoprofen group and 45 to the placebo group. The demographic characteristics of the two groups were similar. There was no difference between the two groups in the postoperative drainage volume: 540 +/- 152 ml in the ketoprofen group versus 585 +/- 195 ml in the placebo group (p=0.22) or period (respectively in days 6 +/- 2 versus 5.6 +/- 1.1; p=0.24). Finally complications did not differ in frequency between the two groups (p=0.54). Discussion: A single dose of 200 mg sustained release ketoprofen did not result in a significant decrease in the postoperative drainage volume compared with placebo. However, the highly significant difference between groups during the first two postoperative days tends to confirm the inflammatory causes of the collected fluid, opening the door for future research.