Introduction. Warfarin remains the preferred oral anticoagulant for the treatment of venous thromboembolism (VTE) in patients with advanced chronic kidney disease (CKD). Although the direct oral anticoagulants (DOACs) have become preferred for treatment of VTE in the general population, patients with advanced CKD were excluded from the landmark trials. Postmarketing, safety data have demonstrated oral factor Xa inhibitors (OFXais) such as apixaban and rivaroxaban to be alternatives to warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation. However, it remains unknown if these safety data can be extrapolated to the treatment of VTE and CKD. Methods. A retrospective cohort study from January 2013 to October 2019 was performed at NYU Langone Health. All adult patients with CKD stage 4 or greater, treated with anticoagulation for VTE, were screened. The primary outcome was tolerability of anticoagulant therapy at 3 months, defined as a composite of bleeding, thromboembolic events, and/or discontinuation rates. The secondary outcomes included bleeding, discontinuations, and recurrent thromboembolism. Results. There were 56 patients evaluated, of which 39 (70%) received warfarin and 17 (30%) received an OFXai (apixaban or rivaroxaban). Tolerability at 3 months was assessed in 48/56 patients (86%). A total of 34/48 (71%) patients tolerated anticoagulation at 3 months, 12 (80%) in the OFXai arm, and 22 (67%) in the warfarin arm ( p = 0.498 ). There were 10/48 (21%) patients that experienced any bleeding events within 3 months, 7 on warfarin, and 3 on apixaban. Recurrence of thromboembolism within 3 months occurred in 3 patients on warfarin, with no recurrence in the OFXai arm. Discussion. OFXais were better tolerated compared to warfarin for the treatment of VTE in CKD, with lower rates of bleeding, discontinuations, and recurrent thromboembolism in a small cohort. Future prospective studies are necessary to confirm these findings.
Background: Immunizations are a common source of pain and anxiety within the pediatric population. Implementation of lidocaine 4% cream, which has a short onset of action, as a standard of care for immunization practices may be feasible. Objective: The objective of this study was to assess the efficacy of lidocaine 4% cream as pain management during immunizations and to evaluate satisfaction of caregivers and nursing staff. Methods: This study was a prospective, randomized, placebo-controlled trial in an urban clinic, which included patients who were ≤ 14 months old accompanied by a caregiver who witnessed the patient receiving an immunization within the previous 7 months. Patients were randomized to receive either lidocaine 4% cream or placebo cream prior to vaccination. Time to cry and duration of cry were recorded. Caregivers completed surveys evaluating attitudes toward pain associated with immunizations as well as their satisfaction with the immunization process through Likert Scale ratings. Nurses completed a questionnaire assessing efficacy and feasibility of lidocaine 4% cream for pain management. Results: A total of 44 patients were included in the analysis in order to achieve 80% power with a p-value < 0.05. Mean duration of cry in patients receiving lidocaine 4% cream was 48.6 seconds in comparison to 65.9 seconds in patients receiving placebo (95%CI, −33.97 seconds to −0.48 seconds; p < 0.05). Conclusions: Lidocaine 4% cream decreased total duration of cry following vaccinations in comparison to placebo with both caregivers and nurses willing to utilize lidocaine 4% cream in a clinic setting if available
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