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Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine.
Neurology 2017; 89(20):2075-2082Neur

Abstract

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.

CLINICALTRIALSGOV 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.

Authors+Show Affiliations

From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA. bwfriedmanmd@gmail.com.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.From the Department of Emergency Medicine (B.W.F., E.I., A.L., K.R., P.E.B., E.J.G.), Albert Einstein College of Medicine, and Department of Pharmacy (C.S., E.Z.), Montefiore Health System, Bronx, NY; Permanente Medical Group and the Kaiser Permanente Division of Research (D.R.V.), Oakland; and Kaiser Permanente Sacramento Medical Center (D.R.V.), CA.

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

29046364

Citation

Friedman, Benjamin W., et al. "Randomized Study of IV Prochlorperazine Plus Diphenhydramine Vs IV Hydromorphone for Migraine." Neurology, vol. 89, no. 20, 2017, pp. 2075-2082.
Friedman BW, Irizarry E, Solorzano C, et al. Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology. 2017;89(20):2075-2082.
Friedman, B. W., Irizarry, E., Solorzano, C., Latev, A., Rosa, K., Zias, E., ... Gallagher, E. J. (2017). Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. Neurology, 89(20), pp. 2075-2082. doi:10.1212/WNL.0000000000004642.
Friedman BW, et al. Randomized Study of IV Prochlorperazine Plus Diphenhydramine Vs IV Hydromorphone for Migraine. Neurology. 2017 Nov 14;89(20):2075-2082. PubMed PMID: 29046364.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized study of IV prochlorperazine plus diphenhydramine vs IV hydromorphone for migraine. AU - Friedman,Benjamin W, AU - Irizarry,Eddie, AU - Solorzano,Clemencia, AU - Latev,Alexander, AU - Rosa,Karolyn, AU - Zias,Eleftheria, AU - Vinson,David R, AU - Bijur,Polly E, AU - Gallagher,E John, Y1 - 2017/10/18/ PY - 2017/04/12/received PY - 2017/08/30/accepted PY - 2017/10/20/pubmed PY - 2017/11/29/medline PY - 2017/10/20/entrez SP - 2075 EP - 2082 JF - Neurology JO - Neurology VL - 89 IS - 20 N2 - 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. CLINICALTRIALSGOV 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. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/29046364/Randomized_study_of_IV_prochlorperazine_plus_diphenhydramine_vs_IV_hydromorphone_for_migraine_ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=29046364 DB - PRIME DP - Unbound Medicine ER -