Clinical experience with patient-controlled analgesia using continuous respiratory monitoring and a smart infusion system

Abstract

Ensuring safe and effective opioid use—a critical therapy that combines high-risk drugs with highly variable patient response—is one of the biggest challenges in medicine. The use of patient-controlled analgesia (PCA) for opioid administration has the potential to greatly improve the use of these agents by allowing patients to self-administer smaller, more frequent doses of an analgesic.1 Despite the effectiveness of this method of administration, the response to opioids varies greatly among individuals, and significant hazards are associated with PCA.1,–8 Patient status can change quickly. Even when PCA pumps are correctly programmed, therapeutic doses of opioids can suppress respiration and decrease heart rate and blood pressure.1,2,4 Comorbidities, diagnosed or undiagnosed, can affect how a patient will respond to a particular opioid dosage, even one that is within approved administration limits.1,2 The increased risk of harm associated with PCA is evident in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. This voluntary database for reporting problems with devices indicated that PCA pumps were associated with 106 adverse drug events (ADEs) (including 22 deaths), compared with 390 ADEs (17 deaths) from large-volume infusion pumps (LVPs), in 2004.9 The installed number of LVPs is approximately 10 times greater than the number of PCA pumps, suggesting that the risk of death from a PCA-related ADE is at least 10 times greater than with LVPs.8 MEDMARX and USP medication-error report data from September 1, 1998, through August 31, 2003, showed that, when PCA pumps are involved, the chance for patient harm increases more than 3.5 times.10