Acta neurologica Scandinavica · 2019
Buccally absorbed vs intravenous prochlorperazine for treatment of migraines headaches.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Fernando Tasha, Lumanauw Debryna Dewi, Youn Sylvia, Shimada Mai, Yadav Kabir, Chappell Bradley, Horeczko Timothy, Tanen David A
Аннотация
OBJECTIVE: To compare the efficacy of buccally absorbed prochlorperazine (BAP) to intravenous prochlorperazine (IVP) for the abortive treatment of migraine headaches.
METHODS: Randomized double-blind trial. Eighty subjects aged 18-65 presenting with migraines to the ED of a safety-net, urban hospital. Subjects were randomized to receive either 6 mg BAP plus 2.25 mL saline IV placebo or 10 mg IVP and buccally absorbed saccharine pill placebo. A 100 mm visual analog scale (VAS) was used to assess pain, nausea, and sedation. Comparisons between groups were analyzed by the Mann-Whitney U test or Fisher's exact test.
RESULTS: Eighty subjects were recruited from November 2016 to December 2017; 79 completed the study. Demographics: 60 women and 19 men with a mean age of 38 ± 12.2 years. Initial mean VAS pain scores were similar between groups (BAP: 78.5 ± 19.9 mm vs IVP: 76.9 ± 19.5 mm). The improvement in mean VAS pain scores over 60 minutes for the BAP group was not significantly different from the IVP group (-54.9 ± 29.7 mm vs -66.7 ± 23.2 mm, respectively; P = 0.08). No significant differences were found in rates of nausea or sedation. Nine subjects in the BAP group required rescue treatment compared to 1 in the IVP group. Five subjects reported symptoms consistent with akathisia in the IVP group while no adverse effects were reported in the BAP group.
CONCLUSION: Buccally absorbed prochlorperazine (BAP) is an effective, non-invasive treatment for migraine headaches when compared to intravenous prochlorperazine (IVP).
METHODS: Randomized double-blind trial. Eighty subjects aged 18-65 presenting with migraines to the ED of a safety-net, urban hospital. Subjects were randomized to receive either 6 mg BAP plus 2.25 mL saline IV placebo or 10 mg IVP and buccally absorbed saccharine pill placebo. A 100 mm visual analog scale (VAS) was used to assess pain, nausea, and sedation. Comparisons between groups were analyzed by the Mann-Whitney U test or Fisher's exact test.
RESULTS: Eighty subjects were recruited from November 2016 to December 2017; 79 completed the study. Demographics: 60 women and 19 men with a mean age of 38 ± 12.2 years. Initial mean VAS pain scores were similar between groups (BAP: 78.5 ± 19.9 mm vs IVP: 76.9 ± 19.5 mm). The improvement in mean VAS pain scores over 60 minutes for the BAP group was not significantly different from the IVP group (-54.9 ± 29.7 mm vs -66.7 ± 23.2 mm, respectively; P = 0.08). No significant differences were found in rates of nausea or sedation. Nine subjects in the BAP group required rescue treatment compared to 1 in the IVP group. Five subjects reported symptoms consistent with akathisia in the IVP group while no adverse effects were reported in the BAP group.
CONCLUSION: Buccally absorbed prochlorperazine (BAP) is an effective, non-invasive treatment for migraine headaches when compared to intravenous prochlorperazine (IVP).