A Clinical Study to Evaluate the Safety and Efficacy of a Patient-controlled Analgesia Pump in Post-surgical Patients

Abstract

Background: The disposable patient-controlled analgesia (PCA) devices are convenient for portability and management. An ideal PCA can be developed as an electronic device with various functions of safety and control. Recently, Accumate 1000Ⓡ was developed as an electronic pump in Korea, and has passed the relevant laboratory criteria of safety and efficacy. We conducted a clinical study on the safety and efficacy when the device is applied to patients. Methods: Fentanyl 1,500μg, ketorolac 180 mg, and ondansetron 8 mg were used for PCA. Continuous infusion rate, bolus dose, and lockout time were set at 1 ml/h, 1 ml, and 15 min, respectively. Fifty patients were monitored for 48 h. The safety of Accumate 1000Ⓡ was evaluated by backflow and siphonage, auto-clamp function, and lockout time intraoperatively. The efficacy was evaluated by the accuracy of bolus and total infused dose, and the satisfaction rates of patients and users. Results: Backflow and siphonage did not occur, and the auto-clamp function was excellent. There was no bolus infusion during lockout time, and the bolus dose was infused accurately after lockout time. For the accuracy of the total infused dose, the mean and median value of performance error between the infused and target doses were －0.55%, and －0.29%, respectively. Noise, button sense, and convenience of cable were rated as satisfactory by 90%, 78%, and 84%, of patients respectively. Conclusions: The safety and efficacy of Accumate 1000Ⓡ were established by clinical trial. We can provide patients with the more precise and optimal analgesia. The history of drug infusion can be used as research data. (Korean J Anesthesiol 2007; 52: 161～5)