Jiang Arlene, Poonai Naveen, Arthur-Hayward Vinolia, Heath Anna
Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.
Department of Pediatrics, Schulich School of Medicine and Dentistry, London, ON, Canada.
Trials. 2025 Aug 7;26(1):280. doi: 10.1186/s13063-025-09009-z.
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 (NO). The primary outcome, distress, will be measured by the Observational Scale of Behavioural Distress - Revised (OSBD-R). Scores from the OSBD-R will be analyzed using a Bayesian mixed effects model with data-driven prior distributions. Samples from the model's posterior distributions will be used to calculate the probability of being best statistic (P), which will effectively rank the interventions. The trial will also evaluate delayed maladaptive behaviours, need for additional physical restraint, adverse events, and need for additional sedation as secondary outcomes. Furthermore, the trial will determine the costs associated with achieving adequate sedation in each treatment arm.
This statistical analysis plan specifies the outcomes and analyses for the ALICE trial. The ALICE trial will provide evidence for the most effective agent for reducing distress in children receiving laceration repairs.
ClinicalTrials.gov NCT05383495. Registered on May 16, 2022.
伤口缝合修复在儿童中是一项常见但令人痛苦的操作。虽然有一系列策略用于处理这种痛苦，但目前尚无标准的护理方案。儿童伤口缝合修复的镇痛（ALICE）试验旨在确定管理伤口缝合修复相关痛苦的最有效药物。本文概述了ALICE试验的统计分析计划。ALICE试验是一项III期、贝叶斯、开放标签试验，将确定在鼻内右美托咪定（IND）、鼻内咪达唑仑（INM）和吸入氧化亚氮（NO）中，哪种药物能最有效地减轻痛苦。主要结局指标“痛苦”将通过修订后的行为痛苦观察量表（OSBD-R）进行测量。OSBD-R的评分将使用具有数据驱动先验分布的贝叶斯混合效应模型进行分析。模型后验分布的样本将用于计算成为最佳统计量的概率（P），这将有效地对干预措施进行排名。该试验还将评估延迟的适应不良行为、额外身体约束的需求、不良事件以及额外镇静的需求作为次要结局。此外，该试验将确定每个治疗组中实现充分镇静的相关成本。
本统计分析计划规定了ALICE试验的结局指标和分析方法。ALICE试验将为接受伤口缝合修复的儿童减轻痛苦的最有效药物提供证据。
ClinicalTrials.gov NCT05383495。于2022年5月16日注册。
