A randomized controlled trial of amitriptyline versus gabapentin for complex regional pain syndrome type I and neuropathic pain in children
A randomized controlled trial of amitriptyline versus gabapentin for complex regional pain syndrome type I and neuropathic pain in children
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DOI：
10.1016/j.sjpain.2016.05.039
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发表时间：
2016-10-01
影响因子：
1.6
通讯作者：
McGrath, Patricia
中科院分区：
文献类型：
--
作者：
Brown, Stephen;Johnston, Bradley;McGrath, Patricia
背景资料：儿童神经性疼痛的治疗具有挑战性，需要药物，物理和心理治疗的多模式方法;然而，很少有证据来指导实践。阿米替林和加巴喷丁是治疗成人神经性疼痛的一线药物，但没有研究检查它们的疗效，或直接比较它们，以确定哪一种可能更好地缓解儿童疼痛和睡眠障碍。方法：获得知情同意后，34名7-18岁的患者被诊断为I型复杂性局部疼痛综合征（CRPS I）或神经性疼痛的患者被随机分配接受阿米替林或加巴喷丁治疗。患者随访6周，评估疼痛强度、睡眠质量和不良事件。我们对研究人员设盲，包括医疗保健提供者、参与者、父母、研究协调员和数据分析员。然后，患者完成定量感觉测试（QST）和心理社会疼痛评估与团队心理学家，在1-3天内开始的trial.Results：在6周的试验结束时，两种药物的患者有重要的减少疼痛，超过了最低限度的重要差异（MID）的1。然而，组间差异无统计学显著性。对于次要结果，我们发现两种药物之间的睡眠评分或不良事件没有统计学显著差异，这表明两种药物改善睡眠评分到相似的程度，是同样safe.Conclusions：阿米替林和加巴喷丁显着降低疼痛强度评分，改善睡眠。两种药物在减轻疼痛或睡眠障碍方面的效果无显著差异。含义：虽然需要更大规模的多中心试验来证实我们的发现，包括长期随访，但这两种药物在6周以上的CRPS I和神经性疼痛一线治疗中似乎都是安全有效的。(C)2016年斯堪的纳维亚疼痛研究协会。Elsevier B. V.出版，保留所有权利。
Background: Treatment of neuropathic pain in children is challenging, and requires a multimodal approach of pharmacologic, physical, and psychological therapies; however there is little evidence to guide practice. Amitriptyline and gabapentin are first-line drugs for treating neuropathic pain in adults, yet no studies have examined their efficacy, or compared them directly, to determine which might be better for pain relief and sleep disturbance in children.Methods: After informed consent was obtained, 34 patients aged 7-18 years diagnosed with complex regional pain syndrome type I (CRPS I) or a neuropathic pain condition were randomly allocated to receive either amitriptyline or gabapentin. Patients were followed for 6 weeks and assessed for pain intensity, sleep quality and adverse events. We blinded study personnel, including health-care providers, participants, parents, the research coordinator and the data analyst. Patients then completed quantitative sensory testing (QST) and a psychosocial pain assessment with the team psychologist, within 1-3 days of the start of the trial.Results: At the end of the 6-week trial, patients on both drugs had important reductions in pain, having surpassed the minimally important difference (MID) of 1. The difference between the groups however was not statistically significant. For the secondary outcomes, we found no statistically significant difference between the two drugs in sleep score or adverse events suggesting that both drugs improve sleep score to a similar degree and are equally safe.Conclusions: Amitriptyline and gabapentin significantly decreased pain intensity scores and improved sleep. There were no significant differences between the two drugs in their effects on pain reduction or sleep disability. Implications: Although larger, multi-centred trials are needed to confirm our findings, including long-term follow-up, both drugs appear to be safe and effective in treating paediatric patients in the first-line treatment of CRPS I and neuropathic pain over 6-weeks. (C) 2016 Scandinavian Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.