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REGIONAL ANESTHESIA AND PAIN MANAGEMENT

A Double-Blinded Evaluation of Propacetamol Versus Ketorolac in Combination with Patient-Controlled Analgesia Morphine: Analgesic Efficacy and Tolerability After Gynecologic Surgery

Giustino Varrassi, MD^*, Franco Marinangeli, MD^*, Felice Agrò, MD, Luigi Aloe, MD, Pompilio De Cillis, MD^§, Aniello De Nicola, MD^||, Francesco Giunta, MD^¶, Stefano Ischia, MD^**, Maria Ballabio, MD, and Silvia Stefanini, PhD

*Department of Anesthesiology and Pain Management, University of L’Aquila, L’Aquila; Department of Anesthesiology, University School of Medicine, LIU-Campus BioMedico, Rome; Anesthesiology Service, Regina Elena Institute, Rome; §Department of Anesthesiology and Intensive Care, G. Rummo Hospital, Benevento; ||Department of Anesthesiology and Intensive Care, S. Leonardo Hospital, Castellammare di Stabia; ¶Department of Anesthesiology and Intensive Care, Department of Surgical Sciences, University of Pisa, Pisa; **Institute of Anesthesiology and Intensive Care, University of Verona, Verona; and Medical Department, UPSAMEDICA, Milan, Italy

Address correspondence and reprint requests to Prof. Giustino Varrassi, Department of Anesthesiology, University of L’Aquila, Via Vetoio, Blocco 11, 67100 L’Aquila, Italy. Address e-mail to giuvarr{at}tin.it

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 double-blinded, 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 ± 4.8 mg) and ketorolac (10.2 ± 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.

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