Poonai Naveen, Arthur-Hayward Vinolia, Ali Samina, Sabhaney Vikram, Doan Quynh, Trottier Evelyne, Gravel Jocelyn, Tran Nam Anh, Bhatt Maala, Eltorki Mohamed, Thull-Freedman Jennifer, Leung Julie, Beer Darcy, Jiang Arlene, Poolacherla Raju, Heath Anna
Department of Pediatrics, Schulich School of Medicine and Dentistry, London, Ontario, Canada.
Department of Epidemiology & Biostatistics, Schulich School of Medicine and Dentistry, London, Ontario, Canada.
PLoS One. 2025 Jun 4;20(6):e0324515. doi: 10.1371/journal.pone.0324515. eCollection 2025.
Lacerations are the most common traumatic reason for children to visit an emergency department (ED), accounting for almost half of all procedures performed. Children experience considerable distress during laceration repair, despite routine application of local anesthetic. Pharmacologic anxiolysis may mitigate the negative practice of forcefully restraining a child, however, evidence for the most effective agent is lacking. We aim to determine the most effective anxiolytic agent for laceration repair in children.
This is a multicentre, phase III, three-arm, adaptive, randomized, open-label, trial. We will include children 2-12 years with a single laceration requiring suture repair in the ED. Participants will be randomized to receive intranasal dexmedetomidine (IND) 3 mcg/kg, intranasal midazolam (INM) 0.4 mg/kg, or inhaled 50% nitrous oxide (N2O). The primary outcome is the weighted mean anxiolysis score using the Observational Scale of Behavioral Distress - Revised (OSBD-R) from initial positioning to tying of the last suture. Secondary outcomes include need for additional anxiolytic, need for physical restraint, adverse events (AEs), and delayed maladaptive behaviors. The primary analysis will be conducted by intention-to-treat. Results will report posterior means, standard deviations (SDs), and 95% high density posterior credible intervals for Total Distress Score on the OSBD-R. We will rank interventions based on the probability that an intervention is superior (Pbest) and the Surface Area Under the Cumulative Ranking Curve (SUCRA) to indicate relative anxiolytic efficacy. The mean difference in Total Distress Score and secondary outcomes will be estimated using Bayesian models.
Ethics approval will be obtained from institutional review boards of the participating sites. Informed consent will be obtained from guardians of all participants in addition to assent from all participants. Study data will be submitted for publication.
Clinicaltrials.gov NCT05383495.
裂伤是儿童前往急诊科就诊最常见的创伤原因，几乎占所有手术操作的一半。尽管常规使用局部麻醉剂，但儿童在裂伤修复过程中仍会经历相当大的痛苦。药物性抗焦虑治疗可能会减轻强行约束儿童的负面做法，然而，目前缺乏关于最有效药物的证据。我们旨在确定儿童裂伤修复中最有效的抗焦虑药物。
这是一项多中心、III期、三臂、适应性、随机、开放标签试验。我们将纳入2至12岁、在急诊科有单一裂伤需要缝合修复的儿童。参与者将被随机分配接受3 mcg/kg的鼻内右美托咪定（IND）、0.4 mg/kg的鼻内咪达唑仑（INM）或吸入50%氧化亚氮（N2O）。主要结局是使用修订后的行为痛苦观察量表（OSBD-R）从初始定位到最后一针缝合时的加权平均抗焦虑评分。次要结局包括是否需要额外的抗焦虑药物、是否需要身体约束、不良事件（AE）以及延迟的适应不良行为。主要分析将采用意向性分析。结果将报告OSBD-R总痛苦评分的后验均值、标准差（SD）和95%高密度后验可信区间。我们将根据干预更优的概率（Pbest）和累积排名曲线下的面积（SUCRA）对干预措施进行排名，以表明相对抗焦虑疗效。总痛苦评分和次要结局的均值差异将使用贝叶斯模型进行估计。
将获得参与研究机构审查委员会的伦理批准。除了获得所有参与者的同意外，还将获得所有参与者监护人的知情同意。研究数据将提交发表。
Clinicaltrials.gov NCT05383495
