ABSTRACT
A large academic cancer center devised a performance improvement plan for special procedures and sedation. A group of interdisciplinary professionals convened to address data collection, complications, and outcomes for non-surgical procedures and sedation. Administrative, medical, and nursing representatives from all areas in which these procedures are performed gathered to assess existing data and data collection methods and to develop an improvement plan. Gastroenterology, pulmonary, diagnostic imaging, intensive care, gynecology, genitourinary, hematology, and anesthesiology specialties were represented. The group was facilitated by staff from the institution's Office of Performance Improvement and co-chaired by an anesthesiologist and a pulmonary specialist. A representative from the Practice Outcomes Department was also an active participant. This article describes group process, design efforts, pilot testing, and analyses for this project. Pilot data are presented as well as a discussion of staff involvement.
Subject(s)
Conscious Sedation/standards , Digestive System Diseases/nursing , Outcome Assessment, Health Care/standards , Program Development/standards , HumansABSTRACT
BACKGROUND: This study investigated the ability of the modified continual reassessment method (MCRM) to determine the maximum tolerated dose of the opioid antagonist nalmefene, which does not reverse analgesia in an acceptable number of postoperative patients receiving epidural fentanyl in 0.075% bupivacaine. METHODS: In the postanesthetic care unit, patients received a single intravenous dose of 0.25, 0.50, 0.75, or 1.00 microg/kg nalmefene. Reversal of analgesia was defined as an increase in pain score of two or more integers above baseline on a visual analog scale from 0 through 10 after nalmefene administration. Patients were treated in cohorts of one, starting with the lowest dose. The maximum tolerated dose of nalmefene was defined as that dose, among the four studied, with a final mean probability of reversal of anesthesia (PROA) closest to 0.20 (ie., a 20% chance of causing reversal). The modified continual reassessment method is an iterative Bayesian statistical procedure that, in this study, selected the dose for each successive cohort as that having a mean PROA closest to the preselected target PROA of 0.20. RESULTS: The modified continual reassessment method repeatedly updated the PROA of each dose level as successive patients were observed for presence or absence of ROA. After 25 patients, the maximum tolerated dose of nalmefene was selected as 0.50 microg/kg (final mean PROA = 0.18). The 1.00-microg/kg dose was never tried because its projected PROA was far above 0.20. CONCLUSIONS: The modified continual reassessment method facilitated determination of the maximum tolerated dose ofnalmefene . Operating characteristics of the modified continual reassessment method suggest it may be an effective statistical tool for dose-finding in trials of selected analgesic or anesthetic agents.
Subject(s)
Analgesia, Epidural , Analgesics, Opioid/therapeutic use , Anesthetics, Local/therapeutic use , Bupivacaine/therapeutic use , Fentanyl/therapeutic use , Naltrexone/analogs & derivatives , Narcotic Antagonists/administration & dosage , Narcotic Antagonists/adverse effects , Pain, Postoperative/drug therapy , Adult , Aged , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/antagonists & inhibitors , Anesthetics, Local/administration & dosage , Anesthetics, Local/antagonists & inhibitors , Bupivacaine/administration & dosage , Bupivacaine/antagonists & inhibitors , Female , Fentanyl/administration & dosage , Fentanyl/antagonists & inhibitors , Humans , Male , Middle Aged , Naltrexone/administration & dosage , Naltrexone/adverse effectsABSTRACT
Postoperative pain can be effectively managed, even in the most complex oncologic procedures. Although the primary agents for treatment of severe pain continue to be opioids, routes of administration and dosing regimen have undergone a dramatic metamorphosis in the past 10 years. The intramuscular injection given every 4 hours has been replaced by patient-controlled analgesia and epidural techniques. Management of ancillary issues that contribute to an increased perception of pain (i.e., stress, depression, anxiety, and inflammation) must be included in an effective multimodal plan. Closer attention to the treatment of pain can obviate the consequences of poorly managed pain, which we are only beginning to understand. In this day of active consumerism in medicine, patients have come to expect improved pain management. Early outcome studies are beginning to confirm the belief that improved pain management translates into between outcomes and earlier dismissals. In the first century BC, Publilius Syrus, a Latin mime, wrote, "There are some remedies worse than the disease." For centuries, pain was inextricably linked to treatment. We may now be approaching a time in the development of medical care when this is no longer true.
