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氯胺酮联合硫酸镁治疗神经病理性疼痛患者的疗效研究(KETAPAIN):一项随机对照试验的研究方案

Effect of ketamine combined with magnesium sulfate in neuropathic pain patients (KETAPAIN): study protocol for a randomized controlled trial.

作者信息

Delage Noémie, Morel Véronique, Picard Pascale, Marcaillou Fabienne, Pereira Bruno, Pickering Gisèle

机构信息

Centre d'Evaluation et de Traitement de la Douleur, CHU de Clermont-Ferrand, F-63003, Clermont-Ferrand, France.

Centre de Pharmacologie Clinique, Bâtiment 3C, CIC Inserm 1405, CHU Clermont-Ferrand, BP 69, F-63003, Clermont-Ferrand, Cedex 1, France.

出版信息

Trials. 2017 Nov 3;18(1):517. doi: 10.1186/s13063-017-2254-3.

Abstract

BACKGROUND

Neuropathic pain is difficult to treat, and the efficacy of recommended drugs remains limited. N-methyl-D-aspartate receptors are implicated, and antagonists are a pharmacological option. Ketamine is widely used in French pain clinics, but without consensus or recommendations. Furthermore, the association of ketamine with magnesium has been poorly studied. The aim of the present study is to evaluate the benefit of ketamine with or without magnesium in refractory neuropathic pain.

METHODS/DESIGN: A randomized, double-blind, crossover, placebo-controlled study will be performed in Clermont-Ferrand University Hospital, Clermont-Ferrand, France. The aim is to evaluate the effect of ketamine with or without magnesium in 22 patients with neuropathic pain. Intravenous ketamine/placebo, ketamine/magnesium sulfate, or placebo/placebo will be administered consecutively to each patient, in random order, once at 5-week intervals. The primary endpoint is the AUC of pain intensity assessed on a 0-10 Numeric Pain Rating Scale for a 5-week period. Data analysis will be performed on an intention-to-treat basis, and all statistical tests (except primary analysis) will be performed with an α risk of 5% (two-sided).

DISCUSSION

Considering the poor efficacy of the drugs available for neuropathic pain, ketamine with or without magnesium sulfate may be a valuable therapeutic option that needs to be standardized.

TRIAL REGISTRATION

EudraCT number- 2015-000142-29 . Registered on April 9, 2015; version 1.4.

摘要

背景

神经性疼痛难以治疗,推荐药物的疗效仍然有限。N-甲基-D-天冬氨酸受体与之相关,拮抗剂是一种药理学选择。氯胺酮在法国疼痛诊所广泛使用,但尚无共识或推荐意见。此外,氯胺酮与镁联合使用的研究较少。本研究的目的是评估氯胺酮联合或不联合镁治疗难治性神经性疼痛的益处。

方法/设计:将在法国克莱蒙费朗市的克莱蒙费朗大学医院进行一项随机、双盲、交叉、安慰剂对照研究。目的是评估氯胺酮联合或不联合镁对22例神经性疼痛患者的疗效。将氯胺酮/安慰剂、氯胺酮/硫酸镁或安慰剂/安慰剂以随机顺序依次静脉注射给每位患者,每隔5周注射一次。主要终点是在0-10数字疼痛评分量表上评估的5周疼痛强度的AUC。数据分析将在意向性分析的基础上进行,所有统计检验(除主要分析外)将在α风险为5%(双侧)的情况下进行。

讨论

考虑到现有治疗神经性疼痛药物的疗效不佳,氯胺酮联合或不联合硫酸镁可能是一种需要标准化的有价值的治疗选择。

试验注册

欧洲药品管理局临床试验编号-2015-000142-29。于2015年4月9日注册;版本1.4。

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