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IRCT2014022116666N1 IRCT 2014-06-22 Mazandaran University of Medical Sciences Comparison of single dose sodium valproate versus Dexamethasone Intravenously for treatment of acute migraine headache Comparison of single dose sodium valproate (Depakine) versus Dexamethasone Intravenously for treatment of acute migraine headache 2014-03-21 anticipated 90 Complete https://irct.ir/trial/15536 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Migraine headache. Intervention 1: Control group: amp dexamethasome 8 mg interavenously. Intervention 2: Intervention: valproat Na(depakine) 400 mg intravenously. 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. <br /> 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. <br /> 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.<br /> 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. <br />
public Narges Karimi
Booali Sina hospital, Pasdaran blv.
Sari Iran (Islamic Republic of) +98 15 1311 0714 n.karimi@mazums.ac.ir Mazandaran University of Medical Sciences scientific Narges Karimi
Booali Sina hospital, Pasdaran blv.
Sari Iran (Islamic Republic of) +98 15 1311 0714 n.karimi@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 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. 15 years 65 years Both G43.9 Migraine, unspecified Treatment - Drugs Treatment - Drugs Control group: amp dexamethasome 8 mg interavenously Intervention: valproat Na(depakine) 400 mg intravenously Headache severity. Timepoint: 30 minutes, 1, 3, 6 and 24 hours after intervention. Method of measurement: Grading 1-4 and qualitative. Photophobia. Timepoint: 1, 3, 6, 24 and 72 hours after intervention. Method of measurement: Questionnaire. Vomiting. Timepoint: 1, 3, 6, 24 and 72 hours after intervention. Method of measurement: Questionnaire. Phonophobia. Timepoint: 1,3,6,24,72 hours. Method of measurement: questionnaire. Mazandaran University of Medical Sciences Approved 2014-03-05 Mazandaran University of Medical Sciences Mazandaran University of Medical Sciences, Jooybar three way, Valiasr blv. Sari Iran (Islamic Republic of)