Benjamin W. Friedman

A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines

Objective: To compare the efficacy of 20 mg of IV metoclopramide, given up to four times over 2 hours as needed for persistent headache, with 6 mg of subcutaneous sumatriptan for the emergency department treatment of migraine headaches. Methods: This was a randomized, double-blind, clinical trial with two intervention arms. The primary endpoint was change in pain intensity as measured by an 11-point pain scale at 2 hours. Secondary endpoints included change in pain intensity at 24 hours and rates of pain-free headache relief at 2 and 24 hours. Results: Two hundred two patients were screened, and 78 of 91 eligible patients were randomized. The two groups had comparable pain scores at baseline. By 2 hours, the change in pain intensity for the metoclopramide group was 7.2 compared with 6.3 for the sumatriptan group (95% CI for difference: −0.2 to 2.2). When compared at 24 hours, the metoclopramide group had improved by 6.1 compared with baseline and the sumatriptan group had improved by 5.0 (95% CI for difference: −0.6 to 2.8). At 2 hours, pain-free rates were 59% in the metoclopramide arm and 35% in the sumatriptan arm (95% CI for difference of 24%: 2 to 46%). The most common side effects at both time points were weakness, dizziness, and drowsiness, which were distributed evenly between the two groups. There were no reports of chest pain within the first 2 hours. The incidence of restlessness, stiffness, and abnormal movements was distributed equally between the two groups. Conclusions: When compared at 2 and 24 hours, aggressive (20 mg dosed up to four times) IV metoclopramide and 6 mg of subcutaneous sumatriptan relieved migraine headache pain comparably. Some secondary endpoints suggest that metoclopramide may be the preferable therapy for migraines presenting to the emergency department.

Parenteral dexamethasone for acute severe migraine headache: meta-analysis of randomised controlled trials for preventing recurrence

Objective To examine the effectiveness of parenteral corticosteroids for the relief of acute severe migraine headache and prevention of recurrent headaches. Design Meta-analysis. Data sources Electronic databases (Cochrane Central Register of Controlled Trials, Medline, Embase, LILACS, and CINAHL), conference proceedings, clinical practice guidelines, contacts with industry, and correspondence with authors. Selection criteria Randomised controlled trials in which corticosteroids (alone or combined with standard abortive therapy) were compared with placebo or any other standard treatment for acute migraine in adults. Review methods Two reviewers independently assessed relevance, inclusion, and study quality. Weighted mean differences and relative risks were calculated and are reported with 95% confidence intervals. Results From 666 potentially relevant abstracts, seven studies met the inclusion criteria. All included trials used standard abortive therapy and subsequently compared single dose parenteral dexamethasone with placebo, examining pain relief and recurrence of headache within 72 hours. Dexamethasone and placebo provided similar acute pain reduction (weighted mean difference 0.37, 95% confidence interval −0.20 to 0.94). Dexamethasone was, however, more effective than placebo in reducing recurrence rates (relative risk 0.74, 95% confidence interval 0.60 to 0.90). Side effect profiles between dexamethasone and placebo groups were similar. Conclusion When added to standard abortive therapy for migraine headache, single dose parenteral dexamethasone is associated with a 26% relative reduction in headache recurrence (number needed to treat=9) within 72 hours.

Diagnostic testing and treatment of low back pain in United States emergency departments: a national perspective.

Study Design. This study is an analysis of the National Hospital Ambulatory Medical Care Survey (NHAMCS), a large sample representative of all emergency department (ED) visits throughout the United States. Objective. To use NHAMCS to describe the frequency of ED visits for the treatment of low back pain, and the diagnostic and therapeutic strategies employed by emergency clinicians. Summary of Background Data. Low back pain is common in the general population. While it accounts for 2.5% of all outpatient office visits, the role of the ED has yet to be described. Methods. We included cases if they had both a reason for visit related to back pain and a primary ED discharge ICD9 code consistent with low back pain. The outcomes included frequency of ED use, and frequency of various diagnostic and therapeutic strategies. Individual patient visits are weighted so that data can be extrapolated to all ED visits throughout the United States. Results. Low back pain related disorders caused 2.63 million (95% CI: 2.32, 2.93 million) annual ED visits in the US. Of all patients with low back pain, 30.5% (28.1, 32.9) had a plain radiograph; 9.6% (95% CI: 7.2, 12.6) had a CT or MRI in 2006 compared with 3.2% (95% CI: 2.0, 5.1) in 2002 (P for trend <0.01). Age and type of insurance were associated with advanced imaging, though geographic region was not. Of medications either administered in the ED or prescribed at discharge, the most frequently used classes were opioids (61.0%, 95% CI: 58.4, 63.5), followed by nonsteroidal anti-inflammatory drugs (49.9%, 95% CI: 47.2, 52.7) and muscle relaxants (43.1%, 95% CI: 40.4, 45.8). Conclusion. Low back pain related disorders are a frequent cause of ED visit. Diagnostic imaging is performed in one-third of all patients. There was a strong secular trend in use of advanced imaging; patients were nearly 3 times as likely to receive a CT or MRI in 2006 as they were 4 years earlier. Although opioids were administered or prescribed to two-thirds of patients, use of therapeutic agents was generally in keeping with guideline recommendations.

Diagnosis and management of the primary headache disorders in the emergency department setting

Headache continues to be a frequent cause of emergency department (ED) use, accounting for 2% of all visits. Most of these headaches prove to be benign but painful exacerbations of chronic headache disorders, such as migraine, tension-type, and cluster. The goal of ED management is to provide rapid and quick relief of benign headache, without causing undue side effects, and to recognize headaches with malignant course. Although these headaches have distinct epidemiologies and clinical phenotypes, there is overlapping response to therapy; nonsteroidals, triptans, dihydroergotamine, and the antiemetic dopamine antagonists may play a therapeutic role for each of these acute headaches. This article reviews the diagnostic criteria and management strategies for the primary headache disorders.

Use of the Emergency Department for Severe Headache. A Population‐Based Study

Background.— Although headache is a common emergency department (ED) chief complaint, the role of the ED in the management of primary headache disorders has rarely been assessed from a population perspective. We determined frequency of ED use and risk factors for use among patients suffering severe headache.

Randomized trial of IV valproate vs metoclopramide vs ketorolac for acute migraine

Objective: We compared the efficacy of IV valproate with metoclopramide and with ketorolac in patients presenting to an emergency department (ED) with acute migraine. Methods: This was a double-blind comparative efficacy trial. Patients were randomized to 1,000 mg sodium valproate, 10 mg metoclopramide, or 30 mg ketorolac, each administered as an IV drip over 15 minutes. The primary outcome was improvement in headache by 1 hour, measured on a verbal 0 to 10 scale, at baseline and 60 minutes later. Important secondary outcomes included (1) need for rescue medication in the ED, and (2) sustained headache freedom. Results: Three hundred thirty patients were enrolled over 30 months beginning in October 2010. Baseline characteristics were comparable among the 3 arms. On the primary outcome, patients receiving IV valproate improved by a mean of 2.8 (95% confidence interval [CI]: 2.3, 3.3) on the 0 to 10 scale; those receiving IV metoclopramide improved by 4.7 (95% CI: 4.2, 5.2); and those receiving IV ketorolac improved by 3.9 (95% CI: 3.3, 4.5). On the secondary endpoints, 69% (95% CI: 60%, 78%) of patients receiving valproate required rescue medication, compared with 33% (95% CI: 24%, 42%) of metoclopramide patients and 52% (95% CI: 42%, 63%) of those assigned to ketorolac. Sustained headache freedom was achieved in 4% (95% CI: 0%, 7%) of those randomized to valproate, 11% (95% CI: 5%, 17%) of metoclopramide patients, and 16% (95% CI: 9%, 23%) receiving ketorolac. In the metoclopramide arm, 6% (95% CI: 3%, 12%) of patients reported feeling “very restless” after investigational medication administration. Conclusions: Valproate was less efficacious than either metoclopramide or ketorolac. Metoclopramide demonstrated superiority to ketorolac on several endpoints. Classification of evidence: This study provides Class I evidence that in ED patients with acute migraine, IV valproate is inferior to metoclopramide or ketorolac in improving headache outcomes.

Recurrence of Primary Headache Disorders After Emergency Department Discharge: Frequency and Predictors of Poor Pain and Functional Outcomes

STUDY OBJECTIVE We determine the frequency of moderate or severe headache during the first 24 hours after an emergency department (ED) visit for a primary headache disorder (such as migraine or tension-type headache), determine the burden of headache during the 3 months after the ED visit, and identify predictors of poor pain and functional outcomes after ED discharge for each of these periods. METHODS In this prospective cohort study, we enrolled headache patients during their initial ED visit, interviewed them by using a standardized questionnaire, and followed them by telephone 24 hours and 3 months after ED discharge. Two emergency physicians classified all headaches according to criteria established by the International Headache Society, using a valid questionnaire and a reproducible technique. RESULTS During an 18-month period, we enrolled 309 primary headache disorder patients in the cohort. The most common primary headache diagnoses assigned to patients were migraine, tension-type headache, and unclassifiable recurrent headache disorder. We successfully obtained follow-up in 94% of patients 24 hours after ED discharge and in 94% 3 months after ED discharge. Moderate or severe headache was present within 24 hours of ED discharge in 31% (95% confidence interval [CI] 25% to 38%) of migraine patients, 19% (95% CI 9% to 36%) of tension-type headache patients, and 27% (95% CI 18% to 38%) of the unclassifiable headache patients. Multiple functionally impairing headaches occurred during the 3 months after ED discharge in 37% of migraine patients (95% CI 30% to 44%), 38% of tension-type headache patients (95% CI 23% to 54%), and 26% of the unclassifiable headache patients (95% CI 17% to 37). After multivariate adjustment, independent predictors of poor 24-hour outcomes were severe baseline pain, baseline nausea, screening positive for depression, and longer duration of headache; the independent predictor of poor 3-month outcomes was Medicaid insurance. CONCLUSION Regardless of type of primary headache disorder, ED headache patients frequently experience pain and functional impairment during the hours and months after discharge.

Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies

To provide evidence‐based treatment recommendations for adults with acute migraine who require treatment with injectable medication in an emergency department (ED). We addressed two clinically relevant questions: (1) Which injectable medications should be considered first‐line treatment for adults who present to an ED with acute migraine? (2) Do parenteral corticosteroids prevent recurrence of migraine in adults discharged from an ED?

A randomized placebo-controlled trial of single-dose IM corticosteroid for radicular low back pain.

Study Design. A randomized, double-blind, placebo-controlled trial of patients with radicular low back pain who present to an emergency department (ED) within 1 week of pain onset. Objective. We hypothesized that a single intramuscular 160 mg dose of methylprednisolone acetate would improve pain and functional outcomes 1 month after ED discharge if the corticosteroid were administered early in disease symptomotology. Summary of Background Data. Parenteral corticosteroids are not recommended for acute, radicular low back pain, though their role in this disease process is ill-defined. To date, this medication class has only been studied in a highly selected group of patients requiring hospitalization. Methods. Adults between the ages of 21 and 50 who presented to an ED with low back pain and a positive straight leg raise test were enrolled. The primary outcome was change in pain intensity on an 11 point numerical rating scale 1 month after ED visit. Secondary outcomes 1 month after ED discharge included analgesic use, functional disability, and adverse medication effects. Results. Six hundred thirty-seven patients were approached for participation, 133 were eligible, and 82 were randomized. Baseline characteristics were comparable between the groups. The primary outcome, a comparison of the mean improvement in pain intensity, favored methylprednisolone by 1.3 (P = 0.10). Some secondary outcomes favored methylprednisolone, such as use of analgesic medication within the previous 24 hours (22% vs. 43%, 95% CI for difference of 20%: 0%–40%) and functional disability (19% vs. 49%, 95% CI for difference of 29%: 9%–49%). Adverse medication effects 1 week after ED discharge were reported by 32% of methylprednisolone and 24% of placebo patients (95% CI for difference of 9%: −12% to 30%). Conclusion. This study was a negative study, though there was a suggestion of benefit of methylprednisolone acetate in a population of young adults with acute radicular low back pain. Further work with a larger sample of patients is needed.

Metoclopramide for Acute Migraine: A Dose-Finding Randomized Clinical Trial

STUDY OBJECTIVE Intravenous metoclopramide is effective as primary therapy for acute migraine, but the optimal dose of this medication is not yet known. The objective of this study is to compare the efficacy and safety of 3 different doses of intravenous metoclopramide for the treatment of acute migraine. METHODS This was a randomized, double-blind, dose-finding study conducted on patients who presented to our emergency department (ED) meeting International Classification of Headache Disorders criteria for migraine without aura. We randomized patients to 10, 20, or 40 mg of intravenous metoclopramide. We coadministered diphenhydramine to all patients to prevent extrapyramidal adverse effects. The primary outcome was improvement in pain on an 11-point numeric rating scale at 1 hour. Secondary outcomes included sustained pain freedom at 48 hours and adverse effects. RESULTS In this study, 356 patients were randomized. Baseline demographics and headache features were comparable among the groups. At 1 hour, those who received 10 mg of intravenous metoclopramide improved by a mean of 4.7 numeric rating scale points (95% confidence interval [CI] 4.2 to 5.2 points); those who received 20 mg improved by 4.9 points (95% CI 4.4 to 5.4 points), and those who received 40 mg improved by 5.3 points (95% CI 4.8 to 5.9 points). Rates of 48-hour sustained pain freedom in the 10-, 20-, and 40-mg groups were 16% (95% CI 10% to 24%), 20% (95% CI 14% to 28%), and 21% (95% CI 15% to 29%), respectively. The most commonly occurring adverse event was drowsiness, which impaired function in 17% (95% CI 13% to 21%) of the overall study population. Akathisia developed in 33 patients. Both drowsiness and akathisia were evenly distributed across the 3 arms of the study. One month later, no patient had developed tardive dyskinesia. CONCLUSION Twenty milligrams or 40 mg of metoclopramide is no better for acute migraine than 10 mg of metoclopramide.