Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.
Bell's Palsy in Children (BellPIC): protocol for a multicentre, placebo-controlled randomized trial.
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DOI：
10.1186/s12887-016-0702-y
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发表时间：
2017-02-13
期刊：
影响因子：
2.4
通讯作者：
PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network
中科院分区：
文献类型：
--
作者：
Babl FE;Mackay MT;Borland ML;Herd DW;Kochar A;Hort J;Rao A;Cheek JA;Furyk J;Barrow L;George S;Zhang M;Gardiner K;Lee KJ;Davidson A;Berkowitz R;Sullivan F;Porrello E;Dalziel KM;Anderson V;Oakley E;Hopper S;Williams F;Wilson C;Williams A;Dalziel SR;PREDICT (Paediatric Research In Emergency Departments International Collaborative) research network
贝尔氏麻痹或急性特发性下运动神经元面瘫的特征是由面神经控制的一侧面部肌肉的突然发作的麻痹或无力。虽然在成人中有高水平的证据表明与安慰剂相比，使用类固醇治疗时，面神经功能的完全恢复率有所改善，但在儿童贝尔麻痹中使用类固醇的类似高水平研究尚不可用。本研究的目的是在一项随机安慰剂对照试验中评估类固醇在儿童贝尔麻痹中的效用。我们正在进行一项随机、三盲、安慰剂对照试验，研究使用泼尼松龙改善贝尔麻痹1个月后的恢复情况。研究中心是澳大利亚和新西兰PREDICT（儿科急诊科研究国际合作）研究网络内的10家医院。将有540名参与者入选。符合条件的患者需要年龄在6个月至< 18岁之间，并在临床医生诊断为贝尔麻痹的72小时内出现在参与医院急诊科之一。如果患者目前使用类固醇或有类固醇禁忌症，或如果有替代诊断，则将被排除。受试者将接受泼尼松龙1 mg/kg/天至最大50 mg/天或口味匹配的安慰剂，持续10天。主要结局是1个月时House-Brackmann量表完全恢复。次要结局包括使用Sunnybrook量表评估恢复情况，使用儿科生活质量量表和儿童健康实用9D量表评估参与者的情绪和功能健康，使用面部疼痛量表修订版或视觉模拟量表评估疼痛，使用联带运动评估问卷评估联带运动，以及1个月、3个月和6个月时的健康利用成本。参与者将被跟踪到12个月，如果没有提前恢复。数据分析将通过意向治疗进行，主要结局以比例差异和根据研究中心和年龄调整的比值比表示。这项大型多中心随机试验将允许明确评估泼尼松龙与安慰剂相比治疗儿童贝尔麻痹的疗效。该研究已在澳大利亚新西兰临床试验登记处注册ACTRN 12615000563561（2015年6月1日）。
Bell’s palsy or acute idiopathic lower motor neurone facial paralysis is characterized by sudden onset paralysis or weakness of the muscles to one side of the face controlled by the facial nerve. While there is high level evidence in adults demonstrating an improvement in the rate of complete recovery of facial nerve function when treated with steroids compared with placebo, similar high level studies on the use of steroids in Bell’s palsy in children are not available. The aim of this study is to assess the utility of steroids in Bell’s palsy in children in a randomised placebo-controlled trial. We are conducting a randomised, triple-blinded, placebo controlled trial of the use of prednisolone to improve recovery from Bell’s palsy at 1 month. Study sites are 10 hospitals within the Australian and New Zealand PREDICT (Paediatric Research in Emergency Departments International Collaborative) research network. 540 participants will be enrolled. To be eligible patients need to be aged 6 months to < 18 years and present within 72 hours of onset of clinician diagnosed Bell’s palsy to one of the participating hospital emergency departments. Patients will be excluded in case of current use of or contraindications to steroids or if there is an alternative diagnosis. Participants will receive either prednisolone 1 mg/kg/day to a maximum of 50 mg/day or taste matched placebo for 10 days. The primary outcome is complete recovery by House-Brackmann scale at 1 month. Secondary outcomes include assessment of recovery using the Sunnybrook scale, the emotional and functional wellbeing of the participants using the Pediatric Quality of Life Inventory and Child Health Utility 9D Scale, pain using Faces Pain Scale Revised or visual analogue scales, synkinesis using a synkinesis assessment questionnaire and health utilisation costs at 1, 3 and 6 months. Participants will be tracked to 12 months if not recovered earlier. Data analysis will be by intention to treat with primary outcome presented as differences in proportions and an odds ratio adjusted for site and age. This large multicenter randomised trial will allow the definitive assessment of the efficacy of prednisolone compared with placebo in the treatment of Bell’s palsy in children. The study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12615000563561 (1 June 2015).