A randomized clinical trial to assess the efficacy of intramuscular droperidol for the treatment of acute migraine headache.

In a recent case series, we reported that intramuscular droperidol appeared to be an effective therapy for the treatment of acute migraine headache. The objective of the study was to further assess the efficacy of intramuscular droperidol for the treatment of acute migraine headache. The study design was a randomized, clinical trial set in a community-based ED. The population was a convenience sample of ED patients who met International Headache Society acute migraine criteria. Exclusions included pregnancy, use of narcotic or phenothiazine medications within 24 hours. For the protocol, patients were randomized to 1 of 2 treatment groups. Patients and physicians were blinded as to the treatment provided. Patients recorded their initial pain on a 100mm Visual Analog Scale (VAS) Patients were randomized to receive either 2.5 mg droperidol intramuscularly; the other group received 1.5 mg/kg meperidine intramuscularly. After 30 minutes patients recorded their pain on the VAS and recorded their preference for the medication on a Likert Scale. Physicians recorded the incidence of any side effects and the need for rescue medication. Statistical analysis consisted of categorical variables that were analyzed by chi-square, continuous interval data by t-tests and ordinal data by Mann-Whitney U test. The primary outcome parameters were mean VAS score change and the percentage of patients who wanted to go home without rescue medication. The study had an 80% power to detect a 26 mm difference in the mean change in VAS between groups. Of the 29 patients who were enrolled, 15 received droperidol. Both groups were similar with respect to age (30.7 +/- 8.9 years droperdol v 32.7 +/- 9.9 years meperidine; P =.59), female sex (73% v 71%; P =.91), mean headache duration (24.7 +/- 28.3 v 18.3 +/- 25.8 hours; P =.55). The droperidol group had a higher mean initial VAS score (88 v 76 mm; P =.03). The 2 groups were similar with regard to outcome, including: mean change in VAS score (47 v 37 mm; P =.33), average Likert score (1.1 v 1.9; P =.85), and the percentage of patients who did not want rescue medication (67% v 57%; P =.61). The incidence of sedation was 6.7 v 14.3%. Akathisia occurred in 13.3% of pts who received droperidol. We found that intramuscular droperidol was similar in efficacy to meperidine with a low incidence of side effects.

RCT Entities:   Population Interventions Outcomes