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急诊科肌肉注射曲马多与双氯芬酸钠治疗急性偏头痛发作的前瞻性、随机、双盲研究。

Intramuscular tramadol vs. diclofenac sodium for the treatment of acute migraine attacks in emergency department: a prospective, randomised, double-blind study.

作者信息

Engindeniz Zulfi, Demircan Celaleddin, Karli Necdet, Armagan Erol, Bulut Mehtap, Aydin Tayfun, Zarifoglu Mehmet

机构信息

Department of Emergency Medicine, Uludag University Medical Faculty, Acil Tip ABD Gorukle, Bursa 16059, Turkey.

出版信息

J Headache Pain. 2005 Jun;6(3):143-8. doi: 10.1007/s10194-005-0169-y. Epub 2005 May 13.

Abstract

The aim of this prospective, randomised, double-blind study was to evaluate the efficacy of intramuscular (IM) tramadol 100 mg in emergency department treatment of acute migraine attack and to compare it with that of IM diclofenac sodium 75 mg. Forty patients who were admitted to our emergency department with acute migraine attack according to the International Headache Society criteria were included in the study. Patients were randomised to receive either tramadol 100 mg (n=20) or diclofenac sodium 75 mg (n=20) intramuscularly. Patients rated their pain on a four-point verbal scale (0=none, 1=mild, 2=moderate, 3=severe) at the beginning of the trial and at 30, 60, 90 and 120 min. At each time interval, severity of associated symptoms were also questioned and recorded. Global evaluation of the drugs by patients and doctors were also recorded. Patients were also asked if they would prefer the same injection in future visits. Any adverse events, whether related to the drug or not, were also recorded. Patients were followed up by telephone 48 h later to check for any headache recurrence. Two-hour pain response rate, which was the primary endpoint, was 80% for both tramadol and diclofenac groups. There were no statistically significant differences among groups in terms of 48-h pain response, rescue treatment, associated symptoms' response, headache recurrence and adverse event rates. Fifteen (75%) patients in the tramadol group and 16 (80%) patients in the diclofenac group stated that they may prefer the same agent for future admissions. In selected patients, tramadol 100 mg IM may be an effective and reliable alternative treatment choice in acute migraine attacks.

摘要

这项前瞻性、随机、双盲研究的目的是评估肌肉注射100毫克曲马多在急诊科治疗急性偏头痛发作中的疗效,并将其与肌肉注射75毫克双氯芬酸钠的疗效进行比较。根据国际头痛协会标准,40例因急性偏头痛发作而入住我院急诊科的患者被纳入研究。患者被随机分为两组,分别肌肉注射100毫克曲马多(n = 20)或75毫克双氯芬酸钠(n = 20)。患者在试验开始时以及30、60、90和120分钟时,根据四点口头量表(0 = 无,1 = 轻度,2 = 中度,3 = 重度)对疼痛进行评分。在每个时间间隔,还询问并记录相关症状的严重程度。同时记录患者和医生对药物的总体评价。还询问患者在未来就诊时是否会选择相同的注射药物。记录任何不良事件,无论是否与药物有关。48小时后通过电话对患者进行随访,以检查是否有头痛复发。作为主要终点的两小时疼痛缓解率,曲马多组和双氯芬酸钠组均为80%。在48小时疼痛缓解、急救治疗、相关症状缓解、头痛复发和不良事件发生率方面,两组之间无统计学显著差异。曲马多组15例(75%)患者和双氯芬酸钠组16例(80%)患者表示,他们在未来入院时可能会选择相同的药物。对于选定的患者,肌肉注射100毫克曲马多可能是急性偏头痛发作时一种有效且可靠的替代治疗选择。

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