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加巴喷丁可降低大手术前高度焦虑患者的术前焦虑和疼痛灾难化:一项盲法随机安慰剂对照试验。

Gabapentin reduces preoperative anxiety and pain catastrophizing in highly anxious patients prior to major surgery: a blinded randomized placebo-controlled trial.

机构信息

Department of Anesthesia and Pain Management, Toronto General Hospital, 200 Elizabeth Street, Eaton North 3 EB 317, Acute Pain Research Unit, Toronto, ON, M5G 2C4, Canada.

出版信息

Can J Anaesth. 2013 May;60(5):432-43. doi: 10.1007/s12630-013-9890-1. Epub 2013 Feb 2.

Abstract

INTRODUCTION

Gabapentin is increasingly being used for the treatment of postoperative pain and a variety of psychiatric diseases, including chronic anxiety disorders. Trials have reported mixed results when gabapentin has been administered for the treatment of preoperative anxiety. We tested the hypothesis that gabapentin 1,200 mg vs placebo would reduce preoperative anxiety in patients who exhibit moderate to high preoperative anxiety.

METHODS

A blinded randomized controlled trial was conducted from September 2009 to June 2011 at the Toronto General Hospital. Following ethics approval and informed consent, 50 female patients with a 0-10 numeric rating scale (NRS) anxiety score of greater than or equal to 5/10 consented to receive either gabapentin 1,200 mg (n = 25) or placebo (n = 25) prior to surgery. Randomization was computer generated, and the Investigational Pharmacy was responsible for the blinding and dispensing of medication. All patients and care providers, including physicians, nurses, and study personnel, were blinded to group allocation. Before administering the study medication, baseline anxiety levels were measured using a NRS, the Spielberger State-Trait Anxiety Inventories, the Pain Catastrophizing Scale, and the Pain Anxiety Symptoms Scale-20. Baseline pain intensity (0-10 NRS) and level of sedation (0-10 NRS and Richmond Agitation-Sedation Scale [RASS]) were also measured. Two hours after the administration of gabapentin or placebo (prior to surgery), patients again rated their anxiety, pain, and sedation levels using the same measurement tools as at baseline. The main outcome was a reduction in preoperative anxiety.

RESULTS

Forty-four patients (22 treated with gabapentin 1,200 mg and 22 treated with placebo) were included in the analysis of the primary outcome. Analysis of covariance in which pre-drug NRS anxiety scores were used as the covariate showed that post-drug preoperative NRS anxiety (Effect size, 1.44; confidence interval [CI] 0.19 to 2.70) and pain catastrophizing (Effect size, 0.43; CI 0.12 to 0.74) scores were significantly lower in the gabapentin group than in the placebo control group, respectively. Post-drug sedation (Effect size, -3.02; CI -4.28 to -1.77) and RASS (Effect size, 0.41; CI 0.12 to 0.71) scores were significantly higher in the gabapentin group than in the placebo group, respectively.

CONCLUSIONS

Administration of gabapentin 1,200 mg prior to surgery reduces preoperative NRS anxiety scores and pain catastrophizing scores and increases sedation prior to entering the operating room. These results suggest that gabapentin 1,200 mg may be a treatment option for patients who exhibit high levels of preoperative anxiety and pain catastrophizing; however, the sedative properties of the medication and the possibility of delayed postoperative discharge in the elective ambulatory population need to be considered.

摘要

简介

加巴喷丁越来越多地被用于治疗术后疼痛和各种精神疾病,包括慢性焦虑症。当加巴喷丁用于治疗术前焦虑症时,试验报告的结果喜忧参半。我们假设,与安慰剂相比,加巴喷丁 1200 毫克将减少中度至高度术前焦虑的患者的术前焦虑。

方法

2009 年 9 月至 2011 年 6 月,在多伦多总医院进行了一项双盲随机对照试验。在获得伦理批准和知情同意后,50 名女性患者的 0-10 数字评定量表(NRS)焦虑评分≥5/10,同意在手术前接受加巴喷丁 1200 毫克(n = 25)或安慰剂(n = 25)。随机化由计算机生成,研究药房负责药物的盲法和分发。所有患者和护理提供者,包括医生、护士和研究人员,均对分组情况不知情。在给予研究药物之前,使用 NRS、斯皮尔伯格状态特质焦虑量表、疼痛灾难化量表和疼痛焦虑症状量表-20 测量基线焦虑水平。还测量了基线疼痛强度(0-10 NRS)和镇静程度(0-10 NRS 和里士满镇静-躁动量表[RASS])。给予加巴喷丁或安慰剂后 2 小时(手术前),患者再次使用与基线相同的测量工具评估焦虑、疼痛和镇静水平。主要结局是术前焦虑的减少。

结果

44 名患者(22 名接受加巴喷丁 1200 毫克治疗,22 名接受安慰剂治疗)被纳入主要结局分析。协方差分析中,使用药物前 NRS 焦虑评分作为协变量,结果显示药物后术前 NRS 焦虑(效应量,1.44;置信区间 [CI] 0.19 至 2.70)和疼痛灾难化(效应量,0.43;CI 0.12 至 0.74)评分在加巴喷丁组明显低于安慰剂对照组。加巴喷丁组的药物后镇静(效应量,-3.02;CI -4.28 至 -1.77)和 RASS(效应量,0.41;CI 0.12 至 0.71)评分明显高于安慰剂组。

结论

术前给予加巴喷丁 1200 毫克可降低术前 NRS 焦虑评分和疼痛灾难化评分,并在进入手术室前增加镇静。这些结果表明,加巴喷丁 1200 毫克可能是术前焦虑和疼痛灾难化程度较高的患者的治疗选择;然而,需要考虑药物的镇静作用以及在择期门诊人群中可能延迟术后出院的可能性。

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