PREEMPTIVE, RANDOMIZED, DOUBLE-BLIND-STUD Y WITH KETOPROFEN IN GYNECOLOGICAL SURGERY FOLLOWING THE BREIVIK STUBHAUG DESIGN/

Study objective: The clinical effect of ketoprofen is based not only o n the inhibition of prostaglandin synthesis. Ketoprofen also acts thro ugh kynurenic acid as a central antagonist on the NMDA receptor. Due t o this central analgesic mechanism of ketoprofen, we expected an analg esic preemptive effect. This study was carried out following the Breiv ik/Stubhaug preemptive effect study design. Methods: In 81 patients sc heduled for gynaecological surgery a randomized double-blind study was performed. Three groups were studied: Group I received preoperative k etoprofen 100 mg i.v., 12 mg/h during surgery and for 48 hours afterwa rds. Group II received 100 mg ketoprofen as a bolus injection before t he end of surgery, thereafter 12 mg/h ketoprofen continuously for 48 h ours. Group III received a placebo during surgery and for 48 hours aft er surgery. The effects were measured postoperatively using a visual a nalog scale (VAS; at rest and on exertion) and the total analgesic con sumption (PCA piritramide) within the first 48 hours after surgery. Fu rthermore, the time to first analgesic request was recorded. The vital signs and side effects were documented. Results: The time to first an algesic request in group I was significantly longer than in groups II and III. In addition, the cumulative postoperative analgesic consumpti on during the first 24 hours after surgery was significantly lower in group I than in group Ill. Furthermore, the combination of an opioid w ith a non-opioid led to a lower pain score (VAS) at rest and on exerti on. Conclusions: We showed a preemptive effect with ketoprofen,which w as expressed significantly both in terms of the time to first analgesi c request and by the lower analgesic consumption in the first 24 hours after surgery.