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Anxiolysis for laceration repair in children: statistical analysis plan for an open-label multicenter adaptive trial
Arlene Jiang1, Naveen Poonai2,3,4, Vinolia Arthur-Hayward2
1Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada. arlene.jiang@sickkids.ca.
Insights
The Anxiolysis for Laceration Repair in Children (ALICE) trial will compare intranasal dexmedetomidine, intranasal midazolam, and nitrous oxide to find the best way to reduce distress during laceration repair in children.
Area of Science:
- Pediatric emergency medicine
- Pharmacological anxiolysis
- Clinical trial methodology
Background:
- Laceration repair in children causes significant distress, with no standard anxiolysis protocol.
- The Anxiolysis for Laceration Repair in Children (ALICE) trial addresses this need.
- This paper details the statistical analysis plan for the ALICE trial.
Purpose of the Study:
- To identify the most effective pharmacological agent for managing distress during pediatric laceration repair.
- To compare intranasal dexmedetomidine (IND), intranasal midazolam (INM), and inhaled nitrous oxide (N2O).
Main Methods:
- Phase III, Bayesian, open-label trial design.
- Primary outcome: distress measured by the Observational Scale of Behavioural Distress - Revised (OSBD-R).
- Bayesian mixed effects model with data-driven priors to rank interventions using probability of being best (Pb).
Main Results:
- Analysis will rank IND, INM, and N2O based on their effectiveness in reducing pediatric distress.
- Secondary outcomes include delayed maladaptive behaviors, need for restraint, adverse events, and additional sedation.
- Cost-effectiveness of sedation in each arm will be evaluated.
Conclusions:
- The ALICE trial's statistical analysis plan is established.
- The trial will provide crucial evidence on the optimal agent for pediatric laceration repair anxiolysis.
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 (Pbest), 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.
