Evidence map›Paper›PMID 40775649›Full record

ArticleTrials2025

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

Arlene Jiang, Naveen Poonai, Vinolia Arthur-Hayward, Anna Heath

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05383495 (Anxiolysis for Laceration Repair in Children), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05383495 phase3recruitingnot on this map

Anxiolysis for Laceration Repair in Children: A Multicenter Adaptive Randomized Trial

TypeinterventionalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2023 to 2026Enrolled300ConditionsLaceration of Skin, Distress, EmotionalArmsDexmedetomidine, Midazolam Nasal Spray, Nitrous oxide
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Arlene JiangChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada. arlene.jiang@sickkids.ca.ORCID http://orcid.org/0009-0000-3158-8650
Naveen PoonaiDepartment of Pediatrics, Schulich School of Medicine and Dentistry, London, ON, Canada.
Vinolia Arthur-HaywardDepartment of Pediatrics, Schulich School of Medicine and Dentistry, London, ON, Canada.
Anna HeathChild Health Evaluative Sciences, The Hospital for Sick Children, Toronto, ON, Canada.

Funding

Academic Medical Organization of Southwestern Ontario R-23-507Canada Research Chairs RGPIN-2021-03366
6 · The paper itself

Abstract

backgroundLaceration 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 (N 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 registrationClinicalTrials.gov NCT05383495. Registered on May 16, 2022.

Indexed as

Anti-Anxiety AgentsChild BehaviorDexmedetomidineLacerationsMidazolamNitrous OxideAdaptive Clinical Trials as TopicAdministration, InhalationAdministration, IntranasalAnesthetics, InhalationBayes TheoremChildChild, PreschoolClinical Trials, Phase III as TopicFemaleHumansAnesthetics, InhalationAnti-Anxiety AgentsDexmedetomidineHypnotics and SedativesMidazolamNitrous OxideBayesian clinical trial“Probability of being best”-statisticProcedural painStatistical analysis planSUCRA

Identifiers

PMID40775649
PMCPMC12333137

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.