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首页> 外文期刊>BMC Pediatrics >A double blind, randomised placebo controlled trial of topical 2% viscous lidocaine in improving oral intake in children with painful infectious mouth conditions
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A double blind, randomised placebo controlled trial of topical 2% viscous lidocaine in improving oral intake in children with painful infectious mouth conditions

机译：局部使用2％粘性利多卡因进行双盲，随机安慰剂对照试验以改善口腔感染性口腔疾病患儿的口服摄入量

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Background Painful infectious mouth conditions are a common presentation to emergency departments. Although self limiting, painful ulcerative lesions and inflamed mucosa can decrease oral intake and can lead to dehydration. Oral analgesia is of limited efficacy and is often refused by the patient. Despite widespread use of oral 2% viscous lidocaine for many years, there is little evidence for its efficacy as an analgesic and in aiding oral intake in children with painful infectious mouth conditions. This study aims to establish the effectiveness of 2% viscous lidocaine in increasing oral intake in these children by comparing it with placebo. Methods/Design This study is a randomised double-blind placebo controlled trial of children between 6 months and 8 years of age with painful infectious mouth conditions defined as gingivostomatitis (herpetic or non herpetic), ulcerative pharyngitis, herpangina and hand foot and mouth disease as assessed by the treating clinician in association with a history of poor oral fluid intake. It will be conducted at a single tertiary paediatric emergency department in Melbourne Australia. 20 patients have already been randomised to receive 2% lidocaine or placebo in a pilot study to determine the sample size in a preplanned adaptive design. A further 80 patients will be randomised to receive either 2% lidocaine or placebo. The placebo agent is identical to lidocaine in terms of appearance, flavour and smell. All clinical and research staff involved, patients and their parents will be blinded to treatment allocation. The primary endpoint is the amount of fluid ingested by each child, expressed in ml/kg, within 60 minutes from the time of administration of the study mixture. Secondary endpoints are the proportion of patients ingesting 5 ml/kg and 10 ml/kg at 30 and 60 minutes after drug administration and the incidence of adverse events. Longer term outcomes will include the proportion of patients requiring hospital admission and length of emergency department stay. Discussion This trial will define the role of 2% lidocaine in the treatment of painful infectious mouth conditions Trial registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12609000566235 .
机译：背景技术口腔感染性口痛是急诊科的常见症状。尽管具有自我限制，但疼痛性溃疡病灶和粘膜发炎会减少口服摄入量并导致脱水。口服镇痛药的疗效有限，通常会被患者拒绝。尽管多年来一直广泛使用2％粘稠的利多卡因口服液，但几乎没有证据表明其可作为止痛药并有助于口腔感染性口腔疾病的儿童口服。这项研究旨在通过与安慰剂进行比较，确定2％粘性利多卡因在增加这些儿童的口服摄入量方面的有效性。方法/设计本研究是一项随机双盲安慰剂对照试验，研究对象为6个月至8岁之间患有疼痛的传染性口腔疾病（定义为牙龈炎（疱疹或非疱疹），溃疡性咽炎，疱疹性咽炎和手足口病）的儿童。由治疗的临床医生评估，并结合不良的口服液摄入史。它将在澳大利亚墨尔本的一个专科小儿急诊科进行。在一项初步研究中，已经有20名患者被随机分配接受2％利多卡因或安慰剂，以通过预先计划的适应性设计确定样本量。另有80名患者将被随机分配接受2％利多卡因或安慰剂治疗。安慰剂在外观，风味和气味方面与利多卡因相同。所有相关的临床和研究人员，患者及其父母将对治疗分配不知情。主要终点是每个孩子在服用研究混合物后60分钟内摄入的体液量，以ml / kg表示。次要终点是给药后30分钟和60分钟摄入5 ml / kg和10 ml / kg的患者比例以及不良事件的发生率。长期结果将包括需要住院的患者比例和急诊科住院时间。讨论该试验将确定2％利多卡因在治疗口腔感染性口痛中的作用。试验注册该试验已在澳大利亚和新西兰临床试验注册中心（ACTRN12609000566235）进行了注册。

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