ABSTRACT
Objectives This article observes the mean daily dose of fentanyl required for adequate sedation in critically ill, mechanically ventilated children randomized to receive dexmedetomidine or placebo.Methods We conducted Dexmedetomidine Opioid Sparing Effect in Mechanically Ventilated Children (DOSE), a multicenter, double-blind, randomized, placebo-controlled, dose-escalating trial. We enrolled children aged 35 weeks postmenstrual to 17 years (inclusive) admitted across 13 pediatric multidisciplinary and cardiac intensive care units. Adequate sedation was based on a State Behavioral Score and Richmond Agitation-Sedation Scale of -1 or lower. Only the first two dexmedetomidine dosing cohorts opened for enrollment, due to early trial closure during the coronavirus 2019 pandemic. Thirty children were randomized over 13 months and included in the analyses.Results Demographic and baseline characteristics were not different between dexmedetomidine and placebo cohorts. Similarly, mean daily fentanyl use was not different, using an unadjusted mixed regression model that considered treatment, time, and a treatment-by-time interaction. Adverse events and safety events of special interest were not different between cohorts.Conclusion The DOSE trial revealed that dexmedetomidine added to fentanyl does not impact safety and may not spare fentanyl use in critically ill children, although the trial did not meet its recruitment goals, due to early closure during the coronavirus 2019 pandemic. More rigorous inpatient pediatric trials like DOSE that study critically ill, mechanically ventilated children are needed. Despite the many obstacles faced, the DOSE trial presents challenges from which the greater research community can learn and use to optimize future therapeutic trials in children.
ABSTRACT
Theoretical basis: The theoretical basis for this case is a focus on vertical integration, first-mover advantage and competitive dynamics. Vertical integration is based on Williamson’s (1979) theory of transaction-cost economics as it relates to vertical integration;the discussion on first-mover advantage is built off of Suarez and Lanzolla’s (2005) dynamics of first-mover advantage;and the analyzes on competitive dynamics derives from the MacMillan et al. (1985) early empirical tests of interfirm rivalry dynamics. Research methodology: The authors conducted extensive research using the following sources: IBISWorld, MergentOnline and academic journals, trade magazines and websites. Additionally, the authors successfully piloted the case on more than 350 undergraduate students enrolled in a business and corporate strategy course. Case overview/synopsis: Peloton used vertical integration to control the creation of its own software, bikes, exercise classes and retail outlets. In doing so, Peloton was one of the first companies in the industry to have near full control of the production process (Gross and Caisman, 2019). Due to this integration, Peloton was one of the fitness equipment industry leaders. However, Peloton’s high level of vertical integration coupled with rapid growth led to lackluster profitability. Given the rise in popularity of in-home exercise equipment, Peloton had room to continue its growth, but the question remained whether it was strategically positioned to do so. Complexity academic level: This case is best taught in undergraduate and graduate strategy courses. For undergraduate courses, it could be incorporated into lessons on competitive dynamics, internal analysis and first-mover advantage and strategic positioning. For graduate courses, it could be incorporated into lessons on vertical integration and delving more in-depth into the long-term sustainability of having a first-mover advantage. © 2021, Emerald Publishing Limited.