IV prochlorperazine plus diphenylhydramine for migraine
Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine
1. Benjamin W. Friedman, MD, MS,
2. Eddie Irizarry, MD,
3. Clemencia Solorzano, PharmD,
4. Alexander Latev, MD,
5. Karolyn Rosa, MD,
6. Eleftheria Zias, RPh,
7. David R. Vinson, MD,
8. Polly E. Bijur, PhD and
9. E. John Gallagher, MD
1. Correspondence to Dr. Friedman: firstname.lastname@example.org
1. Published online before print October 18, 2017, doi: http://x.oi.rg/0.212/NL.000000000004642Neurology 10.1212/WNL.0000000000004642
Objective: To determine outcomes among patients with migraine in the emergency department (ED) who receive IV hydromorphone vs IV prochlorperazine + diphenhydramine.
Methods: This study was conducted in 2 EDs in New York City. Patients who met international criteria for migraine were eligible for participation if they had not used an opioid within the previous month. Clinicians, participants, investigators, and research personnel were blinded to treatment. Patients were randomized in blocks of 4. Participants received hydromorphone 1 mg or prochlorperazine 10 mg + diphenhydramine 25 mg. Diphenhydramine was administered to prevent akathisia, a common side effect of IV prochlorperazine. The primary outcome was sustained headache relief, defined as achieving a headache level of mild or none within 2 hours of medication administration and maintaining that level for 48 hours without the requirement of rescue medication. A planned interim analysis was conducted once 48-hour data were available for 120 patients.
Results: The trial was halted by the data monitoring committee after 127 patients had been enrolled. The primary outcome was achieved in the prochlorperazine arm by 37 of 62 (60%) participants and in the hydromorphone arm by 20 of 64 (31%) participants (difference 28%, 95% confidence interval 12–45, number needed to treat 4, 95% confidence interval 2–9).
Conclusions: IV hydromorphone is substantially less effective than IV prochlorperazine for the treatment of acute migraine in the ED and should not be used as first-line therapy.
ClinicalTrials.gov identifier: NCT02389829.
Classification of evidence: This study provides Class I evidence that for patients in the ED with migraine, IV prochlorperazine + diphenhydramine is superior to IV hydromorphone.
One of many studies showing certain safe, non-narcotic drugs that work better than opioids in the emergency room.