This review aims to evaluate the literature on the safety and efficacy of novel toxoid vaccines for the prophylaxis of Clostridium difficile infections (CDI) in healthy adults. Literature searches for clinical trials were performed through MEDLINE, ClinicalTrials.gov, and Web of Science using the keywords bacterial vaccines, Clostridium difficile, and vaccine. English-language clinical trials evaluating the efficacy and/or safety of Clostridium difficile toxoid vaccines that were completed and had results posted on ClinicalTrials.gov or in a published journal article were included. Six clinical trials were included. The vaccines were associated with mild self-reported adverse reactions, most commonly injection site reactions and flu-like symptoms, and minimal serious adverse events. Five clinical trials found marked increases in antibody production in vaccinated participants following each dose of the vaccine. Clinical trials evaluating C. difficile toxoid vaccines have shown them to be well tolerated and relatively safe. Surrogate markers of efficacy (seroconversion and geometric mean antibody levels) have shown significant immune responses to a vaccination series in healthy adults, indicating that they have the potential to be used as prophylaxis for CDI. However, more research is needed to determine the clinical benefits of the vaccines.
Background:The use of adjunct, non-opioid agents is integral for pain control following total hip and knee arthroplasty. Literature comparing safety profiles of intravenous acetaminophen versus opioids is lacking.Objective:To determine whether there is a difference in frequency and type of adverse effects between intravenous acetaminophen–treated and non-intravenous acetaminophen–treated patients. Primary safety endpoints included any adverse effect noted in the electronic medical record post-surgically. Secondary endpoints included changes in laboratory values, vital signs, and pain scores.Methods:This is a retrospective, matched, cohort study with data collected from electronic medical records. Adverse effects were collected from progress notes, nursing notes, and post-operative notes. Mean pain score was measured by the 11-point visual analog scale over a 72-h period.Results:A total of 609 patients who underwent a total hip or knee replacement were included. In all, 406 patients were treated with intravenous acetaminophen, and 203 patients received medication management without intravenous acetaminophen. More patients treated with intravenous acetaminophen experienced an adverse effect compared to patients who did not receive intravenous acetaminophen (91.63% versus 84.73%; p = 0.012). Mean cumulative acetaminophen exposure was similar in the intravenous acetaminophen group (7704.89 ± 2558.6 versus 7260.1 ± 3016.09 mg; p = 0.07). Mean opioid use was similar in the intravenous acetaminophen group as compared to the non-intravenous acetaminophen group (209.61 ± 555.09 versus 163.89 ± 232.44 mg; p = 0.152). Significantly higher mean pain scores were found in the intravenous acetaminophen group during the 72-h post-surgery period as compared with non-intravenous acetaminophen-treated patients.Conclusion:The increased utilization of intravenous acetaminophen in multimodal pain management did not result in an improved safety or tolerability profile or reduced opioid utilization in orthopedic patients.
Liposomal bupivacaine demonstrated statistically significant impact in pain control in the first 36 hours, but by the end of the 72-hour interval, it was comparable to RPB in postoperative pain management. Using bupivacaine liposome did provide direct and total cost savings compared with RPB.
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