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临床试验/IRCT2014022116666N1
IRCT2014022116666N1已完成未知

Comparison of single dose sodium valproate (Depakine) versus Dexamethasone Intravenously for treatment of acute migraine headache

Mazandaran University of Medical Sciences0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
90

研究概览

简要总结

Background: Migraine headache is a chronic and disabling primary headache in adult. Oral sodium valproate was approved as prophylaxis therapy for this disorder but the effectiveness and tolerability of intravenous valproate as abortive therapy is still not clear.
Methods: We conducted a double-blind, randomized clinical trial for 90 patients between the ages of 18 to 65 years who were referred to emergency department with moderate to severe acute migraine headache. Patients were randomized to receive either dexamethasone or valproate sodium intravenously. Our primary outcome measure was the pain relief after half an hour, 1, 3, 6-hour after injection of drugs. For data analysis, Pearson chi square and T test were employed.
Results: Of the 90 patients, eighty patients were investigated. The percentage of headache improvement at 0.5 hour after treatment was 55 and 67.5% in valproate and dexamethasone group, respectively. The severity of pain with VAS score pre-treatment and half an hour post-treatment had been shown as 9.05±0.90 and 3.8±3.09 at Valproate group and 8.92±0.79 and 3.10±2.73 at Dexamethasone group, respectively. There was no significant different between the two groups.
Conclusion: This RCT trial showed that rapid intravenous injection of 400 mg Valproate (single dose) has similar effects with Dexamethasone in the improvement of acute migraine headache.

研究设计

研究类型
Interventional

入排标准

年龄范围
15 years 至 65 years(—)
性别
All

入选标准

  • age between 15-65 years old; acute migraine headache according to criteria IHS; duration lower than 48 hours; history of migraine headache from 6 month ago; no consumption NSAID from 24 hours ago and valproate Na as prophylaxis from 2 weeks ago. Exclusion criteria: pregnancy; breastfeeding; fever; allergy to drugs; peptic ulcer, GIB from 1 year ago; diabetes melitus and liver disorder and urea cycle defect.

排除标准

  • 未提供

研究者

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