The analgesic efficacy and tolerance of ketoprofen (100 mg) combined with morphine in patient-controlled analgesia after orthopaedic surgery.

Abstract

EDITOR: A combination of ketorolac and morphine is useful in treating pain after orthopaedic surgery [1]. Patient-controlled analgesia (PCA) is an excellent form of postoperative pain relief that has a number of benefits, including painless intravenous (i.v.) delivery, analgesia and patient satisfaction [2]. We have tested the hypothesis that the combination of ketoprofen (100 mg) and morphine versus placebo and morphine would lead to a reduction in morphine consumption and would provide better or equal postoperative pain relief than the use of either analgesic alone. A total of 97 patients aged 18-70 years, ASA classification I-II, undergoing orthopaedic surgery (of the knee, hip, ankle, foot or elbow) with a baseline pain score visual analogue scale (VAS) better than 50 mm at the end of operation were studied in eight centres located in France. Two groups of patients were treated in a double-blind and randomized study. The first group (46 patients) received ketoprofen (100 mg) combined with morphine (K + M), and a second group (51 patients) received placebo combined with morphine (P + M). For each patient, every 8 h during the next 24 h, ketoprofen (100 mg) or placebo was given by i.v. infusion for 30 min. Morphine was administered using a PCA system. There were no significant difference concerning demographic data and clinical variables between the two groups in the intention to treat (ITT) and the per protocol (PP) populations. The total amount of morphine consumption in the ITT population was significantly reduced in the K + M group compared to the P +M group (P=0.0018), with an average saving of morphine of 14.7 mg when ketoprofen was added (Table 1). The results were similar in the PP population.Table 1: ITT and PP populations - total amount of morphine consumption In both treatment groups, adverse events (nausea, vomiting and urinary retention) were similar with no statistically significant differences between them. Overall, 23 (50.0%) patients had at least one adverse event relating to treatment in the K + M group and 24 (47.1%) patients in the P + M group. General satisfaction judged by patients using a satisfaction verbal scale in the ITT population was significantly better in the K + M group than in the P + M group (P = 0.0475). This trial has demonstrated that the addition of ketoprofen to patient-controlled morphine therapy after operation (a) leads to a reduction of morphine consumption, (b) allows the analgesic effect to be maintained at an appropriate level compared to morphine alone over 24 h after operation, and (c) this backs up the central analgesia effect. We have also shown that a combination of ketoprofen and morphine is useful to treat severe pain after orthopaedic surgery. Moreover, this randomized double-blind study showed a morphine-sparing effect confirming the results of Vathana's open study [3]. J. L. DIDAILLER Clinique La Sagesse, Service d'Orthopédie, 4 place Saint-Guénolé 35013 Rennes, France L. DOMINICI Centre Hospitalier, 81 rue Dr Grange 73300 Saint-Jean de Maurienne, France M. DIB C. COHEN Laboratoires Rhône-Poulenc Rorer, 15 rue de la Vanne, 92545 Montrouge Cedex France THE STUDY GROUP OF KETOPROFEN (No. 405)