M. Coppola et al., RANDOMIZED, PLACEBO-CONTROLLED EVALUATION OF PROCHLORPERAZINE VERSUS METOCLOPRAMIDE FOR EMERGENCY DEPARTMENT TREATMENT OF MIGRAINE HEADACHE, Annals of emergency medicine, 26(5), 1995, pp. 541-546
Study objective: To determine the comparative efficacy of IV metoclopr
amide and prochlorperazine for the initial emergency department treatm
ent of migraine headache. Design: Prospective, randomized, double-blin
d, placebo-controlled trial. Setting: Military community hospital ED w
ith an annual census of 75,000. Participants: Seventy consenting adult
s from a convenience sample of patients presenting with migraine heada
che similar to that experienced in at feast one prior episode. Exclusi
on criteria were pregnancy, fever, signs of meningismus, altered senso
rium, drug or alcohol use, oxygen saturation less than 90%, recent tra
uma or seizure, ''worst headache,'' abnormal blood pressure, recent (w
ithin 48 hours) use of metoclopramide or prochlorperazine, and allergy
to metoclopramide or prochlorperazine. Interventions: In a random man
ner, each subject received a 2-mL IV injection of identical-appearing
fluid containing metoclopramide (10 mg), prochlorperazine (10 mg), or
saline solution (placebo). No other analgesics or medications were adm
inistered during the initial study period; rescue agents were administ
ered by the choice of the treating physician after all data were colle
cted. Measurements: Patients scored their nausea, pain, and sedation b
efore receiving the 2-mL injections and at 30 minutes after injection.
Ten-centimeter nonhatched visual analog scales were used far these me
asurements, with distance from the left end (zero) calculated for each
use. Clinically important successful treatment was defined a priori a
s achievement of the following criteria: patient satisfaction and eith
er a decrease of 50% or more in the 30-minute pain score (compared wit
h the initial score) or an absolute pain score of 2.5 cm or less. Fail
ure to achieve these criteria constituted treatment failure. Differenc
es between groups were analyzed with the Kruskal-Wallis ANOVA and chi(
2) tests. Data are reported as frequency percentages and median values
, with a two-tailed P value of .05 or less considered significant. Res
ults: Nausea, pain, and sedation scores were similar in all three grou
ps before therapy. Thirty minutes after treatment, pain scores differe
d among those treated with prochlorperazine (1.1 cm), with metoclopram
ide (3.9 cm), and with placebo (6.1 cm, P = .003). Clinical success oc
curred more commonly after treatment with prochlorperazine (82%) than
after metoclopramide (46%) or placebo (29%, P = .03). However, metoclo
pramide and placebo scores did not differ (P = .14). Nausea tended to
be improved after prochlorperazine, compared with metoclopramide or pl
acebo, at 30 minutes (P = .64). Four patients (6%) returned to the ED
for relapse of migraine headache within 24 hours (three in the placebo
group and one in the metoclopramide group). Conclusion: IV prochlorpe
razine relieves the headache and tends to improve nausea better than m
etoclopramide in ED patients with acute migraine headache.