Double-Blind, Multicenter Trial to Compare the Efficacy of Intramuscular Dihydroergotamine Plus Hydroxyzine Versus Intramuscular Meperidine Plus Hydroxyzine for the Emergency Department Treatment of Acute Migraine Headache☆,☆☆,★,★★
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INTRODUCTION
There is no universally accepted, standard regimen for the abortive therapy of acute migraine headache. Opioid analgesics are commonly used in the emergency department treatment of migraine, and meperidine (MEP) has served as a reference drug in several comparative clinical trials for acute migraine.1, 2, 3, 4, 5, 6 The use of parenteral opioids in the ED is associated with several disadvantages relating to the encouragement of spurious presentations for drug seeking and difficulties with
Enrollment
Patients with a chief complaint of headache presenting to the EDs at 11 general hospitals (sites) from November 1991 to August 1992 were identified to study personnel by ED nursing staff, then approached and screened for enrollment. Screening and enrollment were not consecutive; patients presenting during times when study personnel were unavailable were not approached. Records were not kept on patients who were screened but refused enrollment. No steps were taken to relieve patients’ pain
Patient characteristics
One hundred seventy-one patients were enrolled and received at least 1 dose of either DHE or MEP. The intent-to-treat population consisted of 170 patients (85 in each group); 1 patient was excluded from the enrolled population because of complete loss of records. Fourteen patients (7 in each group) were excluded from the analysis of efficacy because of protocol violations. One of these patients was demonstrated after study enrollment to have meningitis that was considered to be unrelated to the
DISCUSSION
This trial was a randomized, controlled study of acute migraine headache treatment in a nonconsecutive convenience sample of ED patients. The study demonstrated that intramuscular DHE+H and MEP+H produce comparable reductions in migraine headache pain. DHE+H resulted in fewer CNS adverse events than the combination of MEP+H overall, and was significantly less likely to provoke dizziness as a complication of therapy. The current study used a dosage of the active control regimen, MEP, that was
Acknowledgements
We gratefully acknowledge the contributions to data analysis of the late Betty Margul, MD, of Novartis Pharmaceuticals Corporation. The authors also offer sincere thanks to the physicians, nurses, and ED personnel who assisted in the conduct of this study, and in particular to the following individuals: Catherine Hamilton, RN, MPH, University of Cincinnati; Sandra Sanford, RN, George Washington University; Thomas E Terndrup, MD, SUNY; and Rita A Manfredi, MD, Alexandria Hospital.
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2012, Pediatric NeurologyA trial of midazolam vs diphenhydramine in prophylaxis of metoclopramide-induced akathisia
2012, American Journal of Emergency Medicine
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From the Department of Emergency Medicine, University Hospital of Cincinnati,* Cincinnati, OH; the Department of Emergency Medicine, George Washington University,‡ Washington DC; Uniformed Services University of the Health Sciences, Bethesda, MD, and Andrews Air Force Base,§ MD; the Department of Emergency Medicine, University of Massachusetts,∥ Worcester, MA; the UCLA Emergency Medicine Center,¶ Los Angeles, CA; the Department of Emergency Medicine, University of North Carolina,# Chapel Hill, NC; the Department of Emergency Medicine, SUNY Health Sciences Center,** Syracuse, NY; the Division of Emergency Medicine and Toxicology, University of California, Davis,‡‡ Sacramento, CA; Emergency Medicine, University of California, San Francisco,§§ San Francisco, CA; the Department of Emergency Medicine, University of Texas, Houston,∥∥ Houston, TX; and Novartis Medical Operations,¶¶ East Hanover, NJ.
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Supported by the Medical Operations Division of Novartis Pharmaceuticals Corporation, East Hanover, NJ.
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Reprint no.47/1/91462
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Address for reprints: Steven C Carleton, MD, PhD Department of Emergency Medicine University of Cincinnati Hospital 231 Bethesda Avenue Cincinnati, OH 45267-0769 513-558-5281 Fax 513-558-5791 E-mail [email protected]