A Double-Blinded Evaluation of Propacetamol Versus Ketorolac in Combination with Patient-Controlled Analgesia Morphine (original) (raw)

1999, Anesthesia & Analgesia

We assessed the relative morphine consumption in a combined analgesic regimen (on-demand morphine plus the nonopioids propacetamol or ketorolac) after gynecologic surgery. Two hundred women randomly received two IV doses of propacetamol 2 g or ketorolac 30 mg in a doubleblinded, double-dummy trial. Patients were monitored for 12 h, and the following efficacy variables were assessed: total dose of morphine, pain intensity, and global efficacy. Safety and tolerability were evaluated by the occurrence of adverse events, especially the presence and intensity of gastrointestinal symptoms. Hemostatic variables were measured 30 and 60 min after the first infusion; arterial blood pressure, heart and respiratory rates, sedation scores, and renal and hepatic function were also assessed. Total morphine requirements were not significantly different between the propacetamol (10.6 Ϯ 4.8 mg) and ketorolac (10.2 Ϯ 4.4 mg) groups. The evolution of pain intensity and the global efficacy also showed similar patterns in the two groups: 70.2% of patients in the propacetamol group rated the efficacy as "good/ excellent" compared with 68.2% in the ketorolac group. There were no clinically significant changes in vital signs or laboratory values and no observed differences between the two groups, although ketorolac slightly, but not significantly, prolonged the bleeding time. Epigastric pain was present in 9% and 15% of patients receiving propacetamol and ketorolac, respectively. There were two adverse events in the propacetamol group and four in the ketorolac group. Propacetamol demonstrates an efficacy similar to that of ketorolac and has an excellent tolerability after gynecologic surgery. Implications: Propacetamol and ketorolac, combined with patient-controlled analgesia morphine, show similar analgesic efficacy after gynecologic surgery. Morphine consumption and pain scores were comparable in the two studied groups. Propacetamol is as effective as ketorolac and has an excellent tolerability after gynecologic surgery. (Anesth Analg 1999;88:611-16) T he multimodal approach to the treatment of postoperative pain aims to achieve optimal analgesia through additive or synergistic drug effects. The advantage of such a strategy is a reduction in the individual drug doses with a concomitant reduction in side effects (1,2). The association of nonsteroidal antiinflammatory drugs (NSAIDs) that affect the arachidonic acid cascade at peripheral sites with opioids that act centrally on specific receptors is effective in different types of surgery (3-6). The recent availability of propacetamol, an injectable prodrug of paracetamol (acetaminophen), has prompted the use of this well known and safe analgesic in clinical settings when the parenteral route is required.