Clinical Study

Influence of Ketoprofen on drainage volume after radical breast cancer surgery: A prospective randomized clinical trial [ISRCTN06628870]

  • Samir Hidar
  • Khadija Soussi
  • Mohamed Bibi
  • Hedi Khairi

Received Date: 28.08.2006 Accepted Date: 17.11.2006 J Turk Ger Gynecol Assoc 2007;8(1):71-75


To determine the effectiveness of Non Steroidal Inflammatory Drug Ketoprofen versus placebo in reducing post-operative drainage duration and volume after breast cancer surgery.


A single-centre prospective, randomized, double blinded controlled study of women scheduled to undergo a simple or modified radical mastectomy. Patients were randomized into Placebo or a single dose of 200 mg sustained release Ketoprofen groups. 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 of 0.80; significance level of 0.05)


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).


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 theory of the collected fluid opening the door for future research.

Keywords: Breast cancer surgery Anti-Inflammatory Agents, Non-Steroidal, Drains, Seroma