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 pharmacol...
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BMC
2025-08-01
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| Online Access: | https://doi.org/10.1186/s13063-025-09009-z |
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| author | Arlene Jiang Naveen Poonai Vinolia Arthur-Hayward Anna Heath |
| author_facet | Arlene Jiang Naveen Poonai Vinolia Arthur-Hayward Anna Heath |
| author_sort | Arlene Jiang |
| collection | DOAJ |
| description | 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 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 best ), 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. Discussion 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. Trial registration ClinicalTrials.gov NCT05383495. Registered on May 16, 2022. |
| format | Article |
| id | doaj-art-443bc493612e48caaad75cb89d161d3e |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
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| spelling | doaj-art-443bc493612e48caaad75cb89d161d3e2025-08-20T03:46:12ZengBMCTrials1745-62152025-08-012611710.1186/s13063-025-09009-zAnxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE)Arlene Jiang0Naveen Poonai1Vinolia Arthur-Hayward2Anna Heath3Child Health Evaluative Sciences, The Hospital for Sick ChildrenDepartment of Pediatrics, Schulich School of Medicine and DentistryDepartment of Pediatrics, Schulich School of Medicine and DentistryChild Health Evaluative Sciences, The Hospital for Sick ChildrenAbstract 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 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 best ), 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. Discussion 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. Trial registration ClinicalTrials.gov NCT05383495. Registered on May 16, 2022. https://doi.org/10.1186/s13063-025-09009-zStatistical analysis planBayesian clinical trialProcedural pain“Probability of being best”-statisticSUCRA |
| spellingShingle | Arlene Jiang Naveen Poonai Vinolia Arthur-Hayward Anna Heath Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE) Trials Statistical analysis plan Bayesian clinical trial Procedural pain “Probability of being best”-statistic SUCRA |
| title | Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE) |
| title_full | Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE) |
| title_fullStr | Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE) |
| title_full_unstemmed | Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE) |
| title_short | Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial (ALICE) |
| title_sort | anxiolysis for laceration repair in children statistical analysis plan for an open label multicenter adaptive trial alice |
| topic | Statistical analysis plan Bayesian clinical trial Procedural pain “Probability of being best”-statistic SUCRA |
| url | https://doi.org/10.1186/s13063-025-09009-z |
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