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一项关于对乙酰氨基酚(扑热息痛)超前镇痛在降低电休克治疗(ECT)后头痛中的作用的随机、双盲、安慰剂对照试验。

A randomized, double-blind, placebo-controlled trial on the role of preemptive analgesia with acetaminophen [paracetamol] in reducing headache following electroconvulsive therapy [ECT].

作者信息

Isuru Amila, Rodrigo Asiri, Wijesinghe Chamara, Ediriweera Dileepa, Premadasa Shan, Wijesekara Carmel, Kuruppuarachchi Lalith

机构信息

Kingswood estate, Paravahera, Kekanadura, Matara, Sri Lanka.

University Psychiatry Unit, Colombo North Teaching Hospital, Ragama, Sri Lanka.

出版信息

BMC Psychiatry. 2017 Jul 28;17(1):275. doi: 10.1186/s12888-017-1444-6.

Abstract

BACKGROUND

Electroconvulsive therapy (ECT) is a safe and efficient treatment for several severe psychiatric disorders, but its use is limited by side effects. Post-ECT headache is one of the commonest side effects. Preemptive analgesia is effective in post-surgical pain management. The most commonly used analgesic is acetaminophen (paracetamol). However, acetaminophen as a preemptive analgesic for post-ECT headache has not been studied adequately. This study was conducted to compare the incidence and severity of post-ECT headache in patients who were administered acetaminophen pre-ECT with a placebo group.

METHODS

This study was a randomised, double-blind, placebo-controlled trial. Sixty-three patients received 1 g acetaminophen and 63 patients received a placebo identical to acetaminophen. The incidence and severity of headache 2 h before and after ECT were compared between placebo and acetaminophen groups. The severity was measured using a visual analog scale. Generalised linear models were used to evaluate variables associated with post ECT headache.

RESULTS

Demographic and clinical variables of placebo and acetaminophen groups were comparable except for the energy level used to induce a seizure. Higher proportion of the placebo group (71.4%) experienced post-ECT headache when compared to the acetaminophen group (p < 0.001). The median pain score for headache was 0 (Inter quartile range: 0-2) in acetaminophen group whereas the score was 2 (IQR: 0-4) in placebo group (P < 0.001). Model fitting showed that the administration of acetaminophen is associated with less post-ECT headache (odds ratio = 0.23, 95% CI: 0.11-0.48, P < 0.001).

CONCLUSION

A significant reduction was seen in both the incidence and severity of post-ECT headache with preemptive analgesia with acetaminophen.

TRIAL REGISTRATION

Ethical approval was granted by an Ethic review committee, University of Kelaniya, Sri Lanka (P/166/10/2015) and the trial was registered in the Sri Lanka Clinical Trials Registry ( SLCTR/2015/27 ).

摘要

背景

电休克疗法(ECT)是治疗多种严重精神疾病的一种安全有效的方法,但其应用受到副作用的限制。ECT后头痛是最常见的副作用之一。超前镇痛在术后疼痛管理中有效。最常用的镇痛药是对乙酰氨基酚(扑热息痛)。然而,对乙酰氨基酚作为ECT后头痛的超前镇痛药尚未得到充分研究。本研究旨在比较ECT前给予对乙酰氨基酚的患者与安慰剂组患者ECT后头痛的发生率和严重程度。

方法

本研究为随机、双盲、安慰剂对照试验。63例患者接受1g对乙酰氨基酚,63例患者接受与对乙酰氨基酚外观相同的安慰剂。比较安慰剂组和对乙酰氨基酚组ECT前后2小时头痛的发生率和严重程度。严重程度采用视觉模拟量表测量。使用广义线性模型评估与ECT后头痛相关的变量。

结果

除用于诱发癫痫的能量水平外,安慰剂组和对乙酰氨基酚组的人口统计学和临床变量具有可比性。与对乙酰氨基酚组相比,安慰剂组ECT后头痛的发生率更高(71.4%)(p<0.001)。对乙酰氨基酚组头痛的中位疼痛评分为0(四分位间距:0-2),而安慰剂组评分为2(四分位间距:0-4)(P<0.001)。模型拟合显示,给予对乙酰氨基酚与较少的ECT后头痛相关(比值比=0.23,95%置信区间:0.11-0.48,P<0.001)。

结论

对乙酰氨基酚超前镇痛可使ECT后头痛的发生率和严重程度显著降低。

试验注册

斯里兰卡凯拉尼亚大学伦理审查委员会批准了伦理许可(P/166/10/2015),该试验已在斯里兰卡临床试验注册中心注册(SLCTR/2015/27)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/03ff/5534025/c3a41113f3cb/12888_2017_1444_Fig1_HTML.jpg

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