BOSTON — New research supports the recommendation that opioids should not be used for patients who come to emergency departments (EDs) with migraine.
In a randomized, double-blind trial of patients presenting with acute migraine, 60% of those who received intravenous prochlorperazine had sustained headache relief within 2 hours that was sustained for at least 48 hours vs 31% of those receiving the opioid hydromorphone intravenously.
This effect was so beneficial that the trial was halted early by the data monitoring committee.
"Basically, patients who got prochlorperazine were twice as likely to have a good outcome, and those who got hydromorphone were twice as likely to have a side effect," lead author Benjamin W. Friedman, MD, Albert Einstein College of Medicine, Bronx, New York, told Medscape Medical News.
Dr Friedman presented the results here at the American Headache Society Annual Scientific Meeting (AHS) 2017.
AHS scientific program chair Peter Goadsby, MD, PhD, professor of neurology at King's College London and the University of California, San Francisco, noted during a premeeting webcast that these findings support treatment guidelines from the AHS for adults presenting to EDs with acute migraine.
"There's no place for intravenous opioids in the treatment of migraine," said Dr Friedman. "As a society, we're proud to highlight new developments that present evidence in a very practical way."
Definitive Study Needed
Dr Friedman noted that more than 50% of patients with migraine receive opioids in the ED, and 25% receive hydromorphone. However, two recent systemic reviews could not identify any randomized studies of the drug for this indication.
"Opioids have been linked to many bad outcomes but are still commonly used," said Dr Friedman. "So we wanted to do a definitive study to answer these issues."
Their study was designed to enroll patients who presented to two EDs in New York City and met criteria for moderate or severe migraine, based on the International Classification of Headache Disorders 3β.
The primary endpoint was the achievement of a "mild or none" level of headache 2 hours after initial treatment that lasted for 2 days (sustained headache relief).
From the start, an interim analysis was planned for when primary outcome data for at least 120 study participants became available. After 127 patients had been enrolled, the trial was halted.
Of these, 63 were randomly assigned to 10 mg of prochlorperazine plus 25 mg of diphenhydramine (70% women; mean age, 32 years) and 64 were assigned to 1 mg of hydromorphone (88% women; mean age, 35 years). Both treatments were administered over 5 minutes.
All patients were also asked if they wanted a second dose of their study medication 60 minutes after their first dose; 8% of the prochlorperazine group vs 31% of the hydromorphone group said yes.
Phone calls were then conducted at various time points after treatment.
Short- and Long-Term Relief
Results showed a 28% difference between the groups for sustained headache relief after one dose that favored prochlorperazine (number needed to treat [NNT], 4; 95% confidence interval [CI], 2 - 9).
Relief after one or two doses was achieved by 60% vs 41% of the groups, respectively (NNT, 6; 95% CI, 3 - 52).
At 1-month follow-up:
Eight percent of those receiving prochlorperazine vs 14% of those receiving hydromorphone had had a return visit to the ED for headache;
Three headache days were reported by each group; and
Scores were 57 vs 58 for the groups, respectively, on the HIT-6 Headache Impact Test.
Finally, adverse events were reported by 11% vs 20% of the groups, respectively.
After the presentation, an audience member asked Dr Friedman if it was possible that the investigators underdosed the hydromorphone at just 1 mg.
"I'm sure there's a dose of it that could have gotten everybody pain free, but the question would be: What are the side effects that come from that?" he replied. He added that 1 mg has been shown in a general acute pain population to be efficacious and safe, "which is why we chose it."
Dr Friedman noted the study was relatively small and he would like to see the findings replicated in future research. "However, there's a lot of data, retrospective studies, et cetera, that suggest that these data are true."
Final Nail in the Coffin?
"This is a very important study for a couple of reasons," session moderator Robert E. Shapiro, professor of neurological sciences at the Larner College of Medicine, University of Vermont in Burlington, told Medscape Medical News.
"One, it points out that opioids are typically not an effective therapy for acute treatment of migraine or other headache disorders," said Dr Shapiro. "But more importantly is that there's another generic medication that's readily available in virtually every ED in the country that is much more effective and easily provided."
"So this is just another piece of evidence to indicate that there really is not a significant role for opioids at all in headache disorders, especially in the emergency department."
When asked if this puts the final nail in the coffin of using opioids in this way, he said that "at least in my perspective," the standard of care among headache specialists is that "that coffin has been closed for a long time."
Dr Friedman and Dr Shapiro have disclosed no relevant financial relationships.
American Headache Society Annual Scientific Meeting (AHS) 2017. Abstract OR-09. Presented June 10, 2017.
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Medscape Medical News © 2017
Cite this: Prochlorperazine Twice as Effective as Opioid Hydromorphone for Acute Migraine in EDs - Medscape - Jun 16, 2017.