A Randomized, Sham-Controlled Trial of Bilateral Greater Occipital Nerve Blocks With Bupivacaine for Acute Migraine Patients Refractory to Standard Emergency Department Treatment With Metoclopramide.

BACKGROUND: Greater occipital nerve block (GONB) is thought to be an effective treatment for acute migraine, though no randomized efficacy data have been published for this indication. We hypothesized that bilateral GONB with bupivacaine would provide greater rates of headache freedom than a sham injection among a population of emergency department (ED) patients who reported persistence of moderate or severe headache despite standard treatment with intravenous metoclopramide. METHODS: This was a randomized clinical trial conducted in 2 urban EDs. Patients with acute migraine who reported persistence of a moderate or severe headache for at least 1 hour or longer after treatment with 10 mg of intravenous metoclopramide were randomized to bilateral GONB with a total of 6 mL of 0.5% bupivacaine or bilateral intradermal scalp injection with a total of 1 mL of 0.5% bupivacaine. The primary outcome was complete headache freedom 30 minutes after the injection. An important secondary outcome was sustained headache relief, defined as achieving a headache level of mild or none in the ED and maintaining a level of mild or none without the use of any additional headache medication for 48 hours. RESULTS: Over a 31 month period, 76 patients were screened for participation and 28 were enrolled, of whom 15 received sham injection and 13 received GONB. This study was stopped before achieving the a priori sample size due to slow enrollment. The primary outcome - headache freedom at 30 minutes - was achieved by 0/15 (0%) of patients in the sham arm and 4/13 (31%) of patients in the GONB arm (95%CI for difference of 31%: 6, 56%, P = .035). The secondary outcome, sustained headache relief for 48 hours, was reported by 0/15 sham patients (0%) and 3/13 (23%) GONB patients (95% CI for difference of 23%: 0, 46%, P = .087). Reported side effects did not differ substantially between the groups. CONCLUSION: GONB may be an effective treatment for ED patients with acute migraine who continue to suffer from moderate or severe headache after administration of intravenous metoclopramide; however, this study was stopped prior to achieving the a priori sample size.

An exploratory study of IV metoclopramide+diphenhydramine for acute post-traumatic headache.

BACKGROUND: Headache is a frequent complaint among the 1.4 million patients who present to US emergency departments (ED) annually following trauma to the head. There are no evidence-based treatments of acute post-traumatic headache. METHODS: This was an ED-based, prospective study of intravenous (IV) metoclopramide 20mg+diphenhydramine 25mg for acute post-traumatic headache. Patients who presented to our EDs with a moderate or severe headache meeting international criteria were enrolled and followed by telephone 2 and 7days later. The primary outcome was "sustained headache relief" (headache level less than "moderate" in the ED, no additional headache medication, and no relapse to headache worse than "mild").We also gathered data on associated symptomotology using the validated Post Concussion Symptom Scale (PCSS). RESULTS: 21 patients were enrolled. Twelve of 20 (60%) patients with available follow-up data reported sustained headache relief. All but one of the 21 enrolled patients (95%) reported improvement of headache to no worse than mild. Seven of 19 (37%) patients with available data reported moderate or severe headache during the 48h after ED discharge. One week later, 5/19 patients reported experiencing headaches "frequently" or "always". The mean Post Concussion Symptom Score improved from 47.5 (SD 29.4) before treatment to 10.9 (SD 14.8) at the time of ED discharge and 11.4 (SD 21.4) at one week after treatment. CONCLUSION: IV metoclopramide 20mg+diphenhydramine 25mg is an effective and well-tolerated medication regimen for patients presenting to the ED with acute post-traumatic headache, though 1/3 of patients report headache relapse after ED discharge and 1/4 of patients report persistent headaches one week later.

Pain One Week After an Emergency Department Visit for Acute Low Back Pain Is Associated With Poor Three-month Outcomes.

BACKGROUND: Low back pain (LBP) is responsible for more than 2.5 million visits to U.S. emergency departments (EDs) annually. Nearly 30% of patients who present to an ED with acute LBP report functional impairment or pain 3 months later. These patients are at risk of chronic LBP, a highly debilitating condition. In this study, we assessed whether three variables assessable shortly after symptom onset could independently predict poor 3-month outcomes among LBP patients who present to an ED. METHODS: This was a planned analysis of data from two randomized comparative effectiveness studies of patients with acute, nontraumatic, nonradicular LBP. Patients were enrolled during an ED visit, contacted by telephone 1 week after the ED visit, and then followed up by telephone 3 months later. The coprimary 3-month outcomes were LBP-related functional impairment and persistent moderate or severe LBP. Two of the three hypothesized predictor variables were assessed during the index visit: 1) the STarT Back Screening Tool score, a nine-item, multidimensional tool validated and widely used in the outpatient setting, and 2) the patient's own anticipated duration of LBP. The third hypothesized predictor was presence of pain assessed by phone 1 week after the ED visit. We then determined whether these three predictor variables were independently associated with poor outcomes at 3 months, after controlling for medication received, age, and sex. RESULTS: A total of 354 patients were enrolled. Of these, 309 (87%) provided 3-month impairment data and 311 (88%) provided 3-month pain data. At 3 months, 122 of 309 (39%) patients reported functional impairment and 51 of 311(16%) patients reported moderate or severe LBP. Among the three hypothesized predictor variables, 58 of 352 (16%) patients with available data reported a moderate or high STarT Back Screening Tool score, 35 of 321 (11%) patients with available data reported anticipated duration of LBP > 1 week, and 235 of 346 (68%) patients reported pain at 1-week telephone follow-up. After age, sex, and medication received were controlled for in a multivariable logistic regression model, only pain at 1 week was independently associated with 3-month impairment (odds ratio [OR] = 2.42, 95% CI = 1.39-4.22) and 3-month moderate or severe pain (OR = 3.83, 95% CI = 1.53-9.58). CONCLUSIONS: More than one-third of patients reported functional impairment 3 months after an ED visit for acute, nontraumatic, nonradicular LBP. Moderate or severe LBP was less common, reported in about half as many patients (16%). Of the three hypothesized predictor variables, only persistent pain at 1 week was independently associated with poor outcomes at 3 months. Despite its important role in the outpatient setting, the STarT Back Tool was not associated with poor outcomes in this ED cohort.

Randomized clinical trial of hydrocodone/acetaminophen versus codeine/acetaminophen in the treatment of acute extremity pain after emergency department discharge.

OBJECTIVES: The objective was to test the hypothesis that hydrocodone/acetaminophen (Vicodin [5/500]) provides more efficacious analgesia than codeine/acetaminophen (Tylenol #3 [30/300]) in patients discharged from the emergency department (ED). Both are currently Drug Enforcement Administration (DEA) Schedule III narcotics. METHODS: This was a prospective, randomized, double-blind, clinical trial of patients with acute extremity pain who were discharged home from the ED, comparing a 3-day supply of oral hydrocodone/acetaminophen (5 mg/500 mg) to oral codeine/acetaminophen (30 mg/300 mg). Pain was measured on a valid and reproducible verbal numeric rating scale (NRS) ranging from 0 to 10, and patients were contacted by telephone approximately 24 hours after being discharged. The primary outcome was the between-group difference in improvement in pain at 2 hours following the most recent ingestion of the study drug, relative to the time of phone contact after ED discharge. Secondary outcomes compared side-effect profiles and patient satisfaction. RESULTS: The median time from ED discharge to follow-up was 26 hours (interquartile range [IQR] = 24 to 39 hours). The mean NRS pain score before the most recent dose of pain medication after ED discharge was 7.6 NRS units for both groups. The mean decrease in pain scores 2 hours after pain medications were taken were 3.9 NRS units in the hydrocodone/acetaminophen group versus 3.5 NRS units in the codeine/acetaminophen group, for a difference of 0.4 NRS units (95% confidence interval [CI] = -0.3 to 1.2 NRS units). No differences were found in side effects or patient satisfaction. CONCLUSIONS: Both medications decreased NRS pain scores by approximately 50%. However, the oral hydrocodone/acetaminophen failed to provide clinically or statistically superior pain relief compared to oral codeine/acetaminophen when prescribed to patients discharged from the ED with acute extremity pain. Similarly, there were no clinically or statistically important differences in side-effect profiles or patient satisfaction. If the DEA reclassifies hydrocodone as a Schedule II narcotic, as recently recommended by its advisory board, our data suggest that the codeine/acetaminophen may be a clinically reasonable Schedule III substitute for hydrocodone/acetaminophen at ED discharge. These findings should be regarded as tentative and require independent validation in similar and other acute pain models.

Use of butterfly needles to draw blood is independently associated with marked reduction in hemolysis compared to intravenous catheter.

OBJECTIVES: Hemolysis of blood samples drawn in the emergency department (ED) is a common problem that can interfere with timely diagnosis and appropriate treatment. The objective of this study was to identify the smallest number of remediable factors that independently increases the risk of hemolysis to design an effective strategy to address this issue. METHODS: This was a prospective, observational, cross-sectional study of blood specimens obtained by ED staff in an urban, academic, adult ED in a tertiary care center. The staff member who drew the specimen recorded data on a standardized data collection instrument about device (intravenous [IV] catheter or butterfly needle), needle size, anatomic site, fullness of collection tube, tourniquet time, and difficulty of venipuncture. Specimens were sent to the laboratory by a vacuum-powered tube system. A standard automated process that measures free hemoglobin was used to identify hemolysis. A multivariable logistic regression and a tabular analysis stratified by device were performed. Ninety-five percent confidence intervals (CIs) were calculated around the odds ratios (ORs) and around the difference between hemolysis rates. RESULTS: Data were collected on 5,118 blood specimens. There were 4,513 specimens with complete data on all characteristics of the blood draw included in the analyses. The overall hemolysis rate was 12.5% (95% CI = 11.6% to 13.5%), 14.6% in blood drawn from IV catheters and 2.7% from butterfly needles (difference = 11.9%; 95% CI = 10.2% to 13.4%). Device was the strongest independent predictor of hemolysis (OR = 7.7; 95% CI = 4.9 to 12.0). In specimens drawn by IV catheter, hemolysis was significantly higher when blood was drawn from locations other than the antecubital fossa, with small-gauge catheters, collection tubes ≤ half full, tourniquet time ≥ 1 minute, and difficult venipuncture. In contrast, none of these factors was associated with hemolysis when blood was drawn by butterfly needle. CONCLUSIONS: The device used to collect blood was the strongest independent predictor of hemolysis in blood samples drawn in the ED in this study. This finding suggests that the most effective strategy to reduce the rate of hemolysis in the ED is to use butterfly needles for phlebotomy rather than IV catheters.

Randomized clinical trial of efficacy and safety of a single 2-mg intravenous dose of hydromorphone versus usual care in the management of acute pain.

OBJECTIVES: The objective was to test the efficacy and safety of 2 mg of intravenous (IV) hydromorphone (Dilaudid) against "usual care" in emergency department (ED) patients with acute severe pain. METHODS: This was a randomized clinical trial. Patients allocated to 2 mg of IV hydromorphone received their medication in a single dose. Those randomized to usual care received any IV opioid, with type, dose, and frequency chosen by the ED attending. All patients received 2 L/min. nasal cannula oxygen. The primary outcome was the difference in the proportion of patients who achieved clinically satisfactory analgesia by 30 minutes. This was defined as the patient declining additional analgesia when asked the question, "Do you want more pain medicine?" A 10% absolute difference was chosen a priori as the minimum difference considered clinically significant. RESULTS: Of 175 subjects randomized to each group, 164 in the 2 mg hydromorphone group and 161 in the usual care group had sufficient data for analysis. Additional pain medication was declined by 77.4% of patients in the 2 mg hydromorphone group at 30 minutes, compared to 65.8% in the usual care group. This difference of 11.6% was statistically and clinically significant (95% confidence interval [CI] = 1.8% to 21.1%). Safety profiles were similar and no patient required naloxone. There was more pruritus in the hydromorphone group (18.3% vs. 8.7%; difference = 9.6%, 95% CI = 2.6% to 16.6%). CONCLUSIONS: Using a simple dichotomous patient-centered endpoint in which a difference of 10% in proportion obtaining adequate analgesia was considered clinically significant, 2 mg of hydromorphone in a single IV dose is clinically and statistically more efficacious when compared to usual care for acute pain management in the ED.

Derivation of an abbreviated instrument for use in emergency department low back pain research: the five-item Roland Morris Questionnaire.

OBJECTIVES: Low back pain (LBP) is a common reason for emergency department (ED) visits in the United States. Pain and functional outcomes after ED visits for LBP tend to be poor. ED-based clinical LBP research is hampered by complexity of available outcome instruments, which can be time-consuming to administer. The purpose of this investigation was to determine if a shorter version of the well-validated and commonly used Roland Morris Disability Questionnaire (RMDQ) would retain the original 24-item instrument's ability to assess functional outcomes accurately in ED patients with LBP. METHODS: The authors used deidentified data obtained from a prospective LBP cohort study, which enrolled 674 patients during index ED visits for LBP, and followed them by telephone 1 week and 3 months later. Five items were selected from the original 24 items of the RMDQ using regression techniques. Internal consistency of the abbreviated scale was measured using Cronbach's alpha. The strength of association between the five-item scale (RM5) and the parent scale was determined at baseline, 1 week, and 3 months. The association between change in the parent scale and change in the RM5 and the change in RM5 that was most closely associated with a minimum clinically significant difference on the RMDQ were also determined. RESULTS: The Cronbach's alpha for the RM5 was 0.88 (95% confidence interval [CI] = 0.87 to 0.89) at baseline, 0.96 (95% CI = 0.96 to 0.96) at 7 days, and 0.97 (95% CI = 0.97 to 0.97) at 3 months. The Pearson correlation coefficient for the RM5 versus the parent scale was 0.93 (R(2)  = 0.86) at baseline, 0.98 (R(2)  = 0.96) at 1 week, and 0.98 (R(2)  = 0.96) at 3 months. The correlations between change from baseline in the abbreviated scale and the parent scale were 0.95 (R(2)  = 0.90) and 0.96 (R(2)  = 0.92) at 7 days and 3 months, respectively. A one-point change in the RM5 has a sensitivity of 96% (95% CI = 93% to 98%) and a specificity of 92% (95% CI = 89% to 94%) for the minimum clinically significant change on the RMDQ. CONCLUSIONS: An abbreviated five-item version of the RMDQ was developed. Pending independent validation, this shortened instrument should streamline ED-based low back pain research.

A randomized controlled trial of a comprehensive migraine intervention prior to discharge from an emergency department.

OBJECTIVES: Patients who use an emergency department (ED) for acute migraine headaches have higher migraine disability scores, lower socioeconomic status, and are unlikely to have used a migraine-specific medication prior to presentation to the ED. The objective was to determine if a comprehensive migraine intervention, delivered just prior to ED discharge, could improve migraine impact scores 1 month after the ED visit. METHODS: This was a randomized controlled trial of a comprehensive migraine intervention versus typical care among patients who presented to an ED for management of acute migraine. At the time of discharge, for patients randomized to comprehensive care, the research team reinforced their diagnosis, shared a migraine education presentation from the National Library of Medicine, provided them with six tablets of sumatriptan 100 mg and 14 tablets of naproxen 500 mg, and if they wished, provided them with an expedited free appointment to the institution's headache clinic. Patients randomized to typical care received the care their attending emergency physicians (EPs) felt was appropriate. The primary outcome was a between-group comparison of the Headache Impact Test (HIT-6) score, a validated headache assessment instrument, 1 month after ED discharge. Secondary outcomes included an assessment of satisfaction with headache care and use of migraine-specific medication within that 1-month period. RESULTS: Over a 19-month period, 50 migraine patients were enrolled. One-month follow-up was successfully obtained in 92% of patients. Baseline characteristics were comparable. One-month HIT-6 scores in the two groups were nearly identical (59 vs. 56, 95% confidence interval [CI] for difference of 3 = -5 to 11), as was dissatisfaction with overall headache care (17% vs. 18%, 95% CI for difference of 1% = -22% to 24%). Patients randomized to the comprehensive intervention were more likely to be using triptans or migraine-specific therapy (43% vs. 0%, 95% CI for difference of 43% = 20 to 63%) 1 month later. CONCLUSIONS: A comprehensive migraine intervention, when compared to typical care, did not improve HIT-6 scores (a validated measure of the effect of migraine on one's daily life) 1 month after ED discharge. Future work is needed to define a migraine intervention that is practical and useful in an ED, where many underserved patients, of necessity, present for care.