Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE).

ABSTRACT:

Background

Laceration repairs are a common, yet distressing procedure in children. While a range of strategies is used to treat this distress, there is currently no standard of care. The Anxiolysis for Laceration Repair in Children (ALICE) trial aims to identify the most effective pharmacological agent to manage laceration repair-associated distress. This paper outlines the statistical analysis plan for the ALICE trial.  The ALICE trial is a phase III, Bayesian, open-label trial that will identify the optimal agent for reducing distress among intranasal dexmedetomidine (IND), intranasal midazolam (INM), and inhaled nitrous oxide (N₂O). The primary outcome, distress, will be measured by the Observational Scale of Behavioural Distress - Revised (OSBD-R). Scores from the OS

SUBMITTER: Jiang A 

PROVIDER: S-EPMC12333137 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature