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Study Objective: We compare the efficacy and adverse effects of 5 oral analgesics in emergency department (ED) patients aged 21 to 64 years with acute musculoskeletal pain., Methods: This was a randomized clinical trial conducted in 2 urban EDs. Patients received 400 mg ibuprofen/1,000 mg acetaminophen, 800 mg ibuprofen/1,000 mg acetaminophen, 30 mg codeine/300 mg acetaminophen, 5 mg hydrocodone/300 mg acetaminophen, or 5 mg oxycodone/325 mg acetaminophen. The primary outcome was change in pain before administration of medication (baseline) to 1 hour postbaseline. A numeric rating scale was used, varying from 0="no pain" to 10="worst imaginable pain." Secondary outcomes included receipt of rescue medication and adverse effects at 1 and 2 hours postbaseline. ANOVA was used to test differences in the primary outcome between treatment groups., Results: Six hundred participants, predominantly men and Latino, were enrolled. Change in pain from baseline to 60 minutes did not differ by treatment (P=.69). The mean change in pain in numeric rating scale units was 400 mg ibuprofen/1,000 mg acetaminophen 3.0 (95% confidence interval [CI] 2.6 to 3.5); 800 mg ibuprofen/1,000 mg acetaminophen 3.0 (95% CI 2.5 to 3.5), 30 mg codeine/300 mg acetaminophen 3.4 (95% CI 2.9 to 3.9), 5 mg hydrocodone/300 mg acetaminophen 3.1 (95% CI 2.7 to 3.5), and 5 mg oxycodone/325 mg acetaminophen 3.3 (95% CI 2.8 to 3.7). Rescue medication was received before 1 hour had elapsed by 2 patients receiving 400 mg ibuprofen/1,000 mg acetaminophen (1.7%), 3 patients receiving 800 mg ibuprofen/1,000 mg acetaminophen (2.5%), zero patients receiving 30 mg codeine/300 mg acetaminophen (0.0%), 3 patients receiving 5 mg hydrocodone/300 mg acetaminophen (2.5%), and zero patients receiving 5 mg oxycodone/325 mg acetaminophen (0.0%) (P=.21). More patients who received opioids were nauseated or vomited compared with those who did not: 6.7% versus 1.7% (5.0% difference; 95% CI 1.7% to 8.2%). The findings at 2 hours were similar., Conclusion: No analgesic was more efficacious than others 1 or 2 hours after baseline. There was significantly more nausea and vomiting among patients treated with opioids., (Copyright © 2020 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: Despite the frequent use of opioids to treat acute pain, the long-term risks and analgesic benefits of an opioid prescription for an individual emergency department (ED) patient with acute pain are still poorly understood and inadequately quantified. Our objective was to determine the frequency of recurrent or persistent opioid use during the 6 months after the ED visit METHODS: This was a prospective, observational cohort study of opioid-naive patients presenting to 2 EDs for acute pain who were prescribed an opioid at discharge. Patients were followed by telephone 6 months after the ED visit. Additionally, we reviewed the statewide prescription monitoring program database. Outcomes included frequency of recurrent and persistent opioid use and frequency of persistent moderate or severe pain 6 months after the ED visit. Persistent opioid use was defined as filling greater than or equal to 6 prescriptions during the 6-month study period., Results: During 9 months beginning in November 2017, 733 patients were approached for participation. Four hundred eighty-four met inclusion criteria and consented to participate. Four hundred ten patients (85%) provided 6-month telephone data. The prescription monitoring database was reviewed for all 484 patients (100%). Most patients (317/484, 66%; 95% confidence interval 61% to 70%) filled only the initial prescription they received in the ED. One in 5 patients (102/484, 21%; 95% confidence interval 18% to 25%) filled at least 2 prescriptions within the 6-month period. Five patients (1%; 95% confidence interval 0% to 2%) met criteria for persistent opioid use. Of these 5 patients, all but 1 reported moderate or severe pain in the affected body part 6 months later., Conclusion: Although 1 in 5 opioid-naive ED patients who received an opioid prescription for acute pain on ED discharge filled at least 2 opioid prescriptions in 6 months, only 1% had persistent opioid use. These patients with persistent opioid use were likely to report moderate or severe pain 6 months after the ED visit., (Copyright © 2019 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: Patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and skeletal muscle relaxants. We compare functional outcomes and pain among patients with acute low back pain who were randomized to a 1-week course of ibuprofen plus placebo versus ibuprofen plus 1 of 3 skeletal muscle relaxants: baclofen, metaxalone, and tizanidine., Methods: This was a randomized, double-blind, parallel-group, 4-arm study conducted in 2 urban emergency departments (EDs). Patients with nonradicular low back pain for less than or equal to 2 weeks were eligible if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a 24-item inventory of functional impairment caused by low back pain. All participants received 21 tablets of ibuprofen 600 mg, to be taken 3 times a day as needed. Additionally, they were randomized to baclofen 10 mg, metaxalone 400 mg, tizanidine 2 mg, or placebo. Participants were instructed to take 1 or 2 of these capsules 3 times a day as needed. All participants received a 10-minute educational session. The primary outcome was improvement on the Roland-Morris Disability Questionnaire between ED discharge and 1week later. Secondary outcomes included pain intensity 1 week after ED discharge (severe, moderate, mild, or none)., Results: Three hundred twenty patients were randomized. One week later, the mean Roland-Morris Disability Questionnaire score of patients randomized to placebo improved by 11.1 points (95% confidence interval [CI] 9.0 to 13.3), baclofen by 10.6 points (95% CI 8.6 to 12.7), metaxalone by 10.1 points (95% CI 8.0 to 12.3), and tizanidine by 11.2 points (95% CI 9.2 to 13.2). At 1-week follow-up, 30% of placebo patients (95% CI 21% to 41%) reported moderate to severe low back pain versus 33% of baclofen patients (95% CI 24% to 44%), 37% of metaxalone patients (95% CI 27% to 48%), and 33% of tizanidine patients (95% CI 23% to 44%)., Conclusion: Adding baclofen, metaxalone, or tizanidine to ibuprofen does not appear to improve functioning or pain any more than placebo plus ibuprofen by 1 week after an ED visit for acute low back pain., (Copyright © 2019 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: We compare the efficacy and safety of intravenous lidocaine with that of hydromorphone for the treatment of acute abdominal pain in the emergency department (ED)., Methods: This was a randomized, double-blind, clinical trial conducted in 2 EDs in the Bronx, NY. Adults weighing 60 to 120 kg were randomized to receive 120 mg of intravenous lidocaine or 1 mg of intravenous hydromorphone. Thirty minutes after administration of the first dose of the study drug, participants were asked whether they needed a second dose of the investigational medication to which they were randomized. Patients were also stratified according to clinical suspicion of nephrolithiasis. The primary outcome was improvement in pain scores of 0 to 10 between baseline and 90 minutes. An important secondary outcome was need for "off-protocol" parenteral analgesics, including opioids and nonsteroidal anti-inflammatory drugs., Results: We enrolled 154 patients, of whom 77 received lidocaine and 77 received hydromorphone. By 90 minutes, patients randomized to lidocaine improved by a mean of 3.8 points on the 0-to-10 scale, whereas those randomized to hydromorphone improved by a mean of 5.0 points (mean difference 1.2; 95% confidence interval 0.3 to 2.2). Need for off-protocol "rescue" analgesics occurred for 39 of 77 lidocaine patients (51%) and 20 of 77 hydromorphone patients (26%) (difference 25%; 95% confidence interval 10% to 40%). Adverse events were comparable between groups. Among the subset of 22 patients with nephrolithiasis, lidocaine patients reported a mean improvement of 3.4 points on the pain scale, whereas hydromorphone patients reported a mean improvement of 6.4 points (mean difference 3.0; 95% confidence interval 0.5 to 5.5)., Conclusion: Intravenous hydromorphone was superior to intravenous lidocaine both for general abdominal pain and a subset of patients with nephrolithiasis. A majority of patients randomly allocated to lidocaine required additional analgesics., (Copyright © 2019 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: As clinicians look to nonnarcotic analgesics in the emergency department (ED), it is essential to understand the effectiveness and adverse effects of nonopioid medications in comparison with existing opioid treatments. Studies of intravenous acetaminophen for acute pain in the ED demonstrate mixed results and suffer from small sample sizes and methodological limitations. This study compares intravenous hydromorphone with intravenous acetaminophen in adult ED patients presenting with acute pain., Methods: This was a prospective, randomized, clinical trial comparing 1 g intravenous acetaminophen with 1 mg intravenous hydromorphone for treatment of adults with severe, acute pain in the ED. The primary outcome was between-group difference in change in numeric rating scale from baseline to 60 minutes postadministration of study medication. Secondary outcomes included the difference in proportion of patients in each group who declined additional analgesia at 60 minutes, received additional medication before 60 minutes, and developed nausea, vomiting, or pruritus., Results: Of 220 subjects randomized, 103 patients in each arm had sufficient data for analysis. At 60 minutes, the mean decrease in numeric rating scale pain score was 5.3 in the hydromorphone arm and 3.3 in the acetaminophen arm, a difference of 2.0 (95% confidence interval [CI] 1.2 to 2.7) favoring hydromorphone. A greater proportion of patients in the hydromorphone arm also declined additional analgesia at 60 minutes (65% versus 44%; difference 21%; (95% CI 8% to 35%). There was no difference in the proportion of patients receiving rescue analgesia before 60 minutes. Significantly more subjects in the hydromorphone group developed nausea (19% versus 3%; difference 16%; 95% CI 4% to 28%) and vomiting (14% versus 3%; difference 11%; 95% CI 0% to 23%)., Conclusion: Although both 1 mg intravenous hydromorphone and 1 g intravenous acetaminophen provided clinically meaningful reductions in pain scores, treatment with hydromorphone provided both clinically and statistically greater analgesia than acetaminophen, at the cost of a higher incidence of nausea and vomiting., (Copyright © 2018 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: Migraine patients continue to report headache during the days and weeks after emergency department (ED) discharge. Dexamethasone is an evidence-based treatment of acute migraine that decreases the frequency of moderate or severe headache within 72 hours of ED discharge. We hypothesize that intramuscular methylprednisolone acetate, a long-acting steroid that remains biologically active for 14 days, will decrease the number of days with headache during the week after ED discharge by at least 1 day compared with intramuscular dexamethasone., Methods: We conducted a randomized, blinded clinical trial comparing intravenous metoclopramide at 10 mg+intramuscular dexamethasone at 10 mg with intravenous metoclopramide at 10 mg+intramuscular methylprednisolone acetate at a dose of 160 mg for patients presenting to 2 different EDs with moderate or severe migraine. Outcomes were assessed by telephone with a standardized instrument. The primary outcome was number of days with headache during the week after ED discharge. Secondary outcomes were complete freedom from headache, without the necessity of additional headache medication for the entire week after ED discharge, and medication preference, as determined by asking the patient whether he or she would want to receive the same medication again., Results: One hundred nine patients received dexamethasone and 111 received methylprednisolone acetate. We obtained primary outcome data from 101 dexamethasone patients and 106 methylprednisolone acetate patients. Dexamethasone patients reported 3.0 headache days and methylprednisolone acetate 3.3 headache days (95% confidence interval for rounded mean difference of 0.4 days: -0.4 to 1.1). Of 107 dexamethasone patients with analyzable data, 10 (9%) reported complete freedom from headache at 1 week versus 6 of 110 (5%) methylprednisolone acetate patients (95% confidence interval for difference of 4%: -3% to 11%). In the dexamethasone group, 76 of 101 (75%) patients would want the same medication again versus 75 of 106 (71%) of methylprednisolone acetate patients (95% confidence interval for difference of 4%: -8% to 17%). Other than injection site reactions, which were more common in the methylprednisolone acetate group, there were no substantial differences in frequency of adverse events., Conclusion: Methylprednisolone acetate does not decrease the frequency of post-ED discharge headache days compared with dexamethasone. Most migraine patients are likely to continue to experience headache during the week after ED discharge., (Copyright © 2018 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: In US emergency departments (EDs), patients with low back pain are often treated with nonsteroidal anti-inflammatory drugs and muscle relaxants. We compare functional outcomes among patients randomized to a 1-week course of naproxen+placebo versus naproxen+orphenadrine or naproxen+methocarbamol., Methods: This was a randomized, double-blind, comparative effectiveness trial conducted in 2 urban EDs. Patients presenting with acute, nontraumatic, nonradicular low back pain were enrolled. The primary outcome was improvement on the Roland-Morris Disability Questionnaire (RMDQ) between ED discharge and 1 week later. All patients were given 14 tablets of naproxen 500 mg, to be used twice a day, as needed for low back pain. Additionally, patients were randomized to receive a 1-week supply of orphenadrine 100 mg, to be used twice a day as needed, methocarbamol 750 mg, to be used as 1 or 2 tablets 3 times per day as needed, or placebo. All patients received a standardized 10-minute low back pain educational session before discharge., Results: Two hundred forty patients were randomized. Baseline demographic characteristics were comparable. The mean RMDQ score of patients randomized to naproxen+placebo improved by 10.9 points (95% confidence interval [CI] 8.9 to 12.9). The mean RMDQ score of patients randomized to naproxen+orphenadrine improved by 9.4 points (95% CI 7.4 to 11.5). The mean RMDQ score of patients randomized to naproxen+methocarbamol improved by 8.1 points (95% CI 6.1 to 10.1). None of the between-group differences surpassed our threshold for clinical significance. Adverse events were reported by 17% (95% CI 10% to 28%) of placebo patients, 9% (95% CI 4% to 19%) of orphenadrine patients, and 19% (95% CI 11% to 29%) of methocarbamol patients., Conclusion: Among ED patients with acute, nontraumatic, nonradicular low back pain, combining naproxen with either orphenadrine or methocarbamol did not improve functional outcomes compared with naproxen+placebo., (Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: We assess the effectiveness of patient-controlled analgesia in the emergency department (ED). We hypothesized that decline in pain intensity from 30 to 120 minutes after initial intravenous opioid administration is greater in patients receiving morphine by patient-controlled analgesia compared with usual care and would differ by a clinically significant amount., Method: This was a pragmatic randomized controlled trial of patient-controlled analgesia and usual care (opioid and dose at physician's discretion) in 4 EDs. Entry criteria included age 18 to 65 years and acute pain requiring intravenous opioids. The primary outcome was decline in numeric rating scale pain score 30 to 120 minutes postbaseline. Secondary outcomes included satisfaction, time to analgesia, adverse events, and patient-controlled analgesia pump-related problems. We used a mixed-effects linear model to compare rate of decline in pain (slope) between groups. A clinically significant difference between groups was defined as a difference in slopes equivalent to 1.3 numeric rating scale units., Results: Six hundred thirty-six patients were enrolled. The rate of decline in pain from 30 to 120 minutes was greater for patients receiving patient-controlled analgesia than usual care (difference=1.0 numeric rating scale unit; 95% confidence interval [CI] 0.6 to 1.5; P<.001) but did not reach the threshold for clinical significance. More patients receiving patient-controlled analgesia were satisfied with pain management (difference=9.3%; 95% CI 3.3% to 15.1%). Median time to initial analgesia was 15 minutes longer for patient-controlled analgesia than usual care (95% CI 11.4 to 18.6 minutes). There were 7 adverse events in the patient-controlled analgesia group and 1 in the usual care group (difference=2.0%; 95% CI 0.04% to 3.9%), and 11 pump-programming errors., Conclusion: The findings of this study do not favor patient-controlled analgesia over usual ED care for acute pain management., (Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: Low back pain causes more than 2.5 million visits to US emergency departments (EDs) annually. Low back pain patients are often treated with nonsteroidal anti-inflammatory drugs and benzodiazepines. The former is an evidence-based intervention, whereas the efficacy of the latter has not been established. We compare pain and functional outcomes 1 week and 3 months after ED discharge among patients randomized to a 1-week course of naproxen+diazepam versus naproxen+placebo., Methods: This was a randomized, double-blind, comparative efficacy clinical trial conducted in an urban health care system. Patients presenting with acute, nontraumatic, nonradicular low back pain of no more than a duration of 2 weeks were eligible for enrollment immediately before discharge from an ED if they had a score greater than 5 on the Roland-Morris Disability Questionnaire, a validated 24-item inventory of functional impairment caused by low back pain. Higher scores on the questionnaire indicate greater functional disability. The primary outcome in the trial was improvement in the score between ED discharge and 1 week later. Secondary outcomes included pain intensity 1 week and 3 months after ED discharge, as measured on a 4-point descriptive scale (severe, moderate, mild, and none). All patients were given 20 tablets of naproxen 500 mg, to be taken twice a day as needed for low back pain. Additionally, patients were randomized to receive either 28 tablets of diazepam 5 mg or identical placebo, to be received as 1 or 2 tablets every 12 hours as needed for low back pain. All patients received a standardized 10-minute low back pain educational session before discharge. Using a between-group mean difference of 5 Roland-Morris Disability Questionnaire points, a previously validated threshold for clinical significance, we calculated the need for at least 100 patients with primary outcome data., Results: Enrollment began in June 2015 and continued for 9 months. Five hundred forty-five patients were screened for eligibility. One hundred fourteen patients met selection criteria and were randomized. Baseline demographic characteristics were not substantially different between the 2 groups. One hundred twelve patients (98%) provided 1-week outcome data. The mean Roland-Morris Disability Questionnaire score of patients randomized to naproxen+diazepam improved by 11 (95% confidence interval [CI] 9 to 13), as did the mean score of patients randomized to naproxen+placebo (11; 95% CI 8 to 13). At 1-week follow-up, 18 of 57 diazepam patients (32%; 95% CI 21% to 45%) reported moderate or severe low back pain versus 12 of 55 placebo patients (22%; 95% CI 13% to 35%). At 3-month follow-up, 6 of 50 diazepam patients (12%; 95% CI 5% to 24%) reported moderate or severe low back pain versus 5 of 53 placebo patients (9%; 95% CI 4% to 21%). Adverse events were reported by 12 of 57 diazepam patients (21%; 95% CI 12% to 33%) and 8 of 55 placebo patients (15%; 95% CI 7% to 26%)., Conclusion: Among ED patients with acute, nontraumatic, nonradicular low back pain, naproxen+diazepam did not improve functional outcomes or pain compared with naproxen+placebo 1 week and 3 months after ED discharge., (Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: We assess the efficacy of a simple pain titration protocol of 1-mg increments of intravenous hydromorphone, given at fixed intervals, driven solely by patient response to a yes/no question., Methods: This was a prospective interventional cohort study of nonelderly adults with acute severe pain defined as requiring intravenous opioids in the judgment of the attending emergency physician. All patients received 1 mg intravenous hydromorphone and 30 minutes later were asked, "Do you want more pain medication?" Patients responding yes received an additional 1 mg of intravenous hydromorphone and were asked the same question 30 minutes after receiving it. Those responding no did not receive additional opioid and were asked the question again 30 minutes later. Each patient was queried 4 times. The primary endpoint was the proportion of patients achieving satisfactory pain control, defined as declining additional pain medication on 1 or more occasions., Results: Of 215 patients enrolled, there were 8 protocol violations, leaving 207 patients with analyzable data; 205 of 207 patients (99%; 95% confidence interval 97% to 100%) achieved satisfactory analgesia at 1 or more points during the study. Nine patients desaturated below 95% on room air, 2 had respiratory rates less than 10 breaths/min, and 2 had pulse rates less than 50 beats/min. No adverse events were associated with amount of hydromorphone received., Conclusion: A pain protocol, based on titration of 1 mg intravenous hydromorphone, driven solely by patient response to a simple standardized question repeated at intervals, resulted in achievement of satisfactory analgesia on at least 1 occasion in 99% of patients., (Copyright © 2015 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: More than 1 million patients present to US emergency departments (EDs) annually seeking care for acute migraine. Parenteral antihistamines have long been used in combination with antidopaminergics such as metoclopramide to treat acute migraine in the ED. High-quality data supporting this practice do not exist. We determine whether administration of diphenhydramine 50 mg intravenously+metoclopramide 10 mg intravenously results in greater rates of sustained headache relief than placebo+metoclopramide 10 mg intravenously., Methods: This was a randomized, double-blind, clinical trial comparing 2 active treatments for acute migraine in an ED. Eligible patients were adults younger than 65 years presenting with an acute moderate or severe headache meeting International Classification of Headache Disorders-2 migraine criteria. Patients were stratified according to presence or absence of allergic symptoms. 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 this level of relief without use of any additional headache medication for 48 hours. Secondary efficacy outcomes included mean improvement on a 0 to 10 verbal scale between baseline and 1 hour, the frequency with which subjects indicated they would want the same medication the next time they present to the ED with migraine, and the ED throughput time. Sample size calculation using a 2-sided α of .05, a β of .20, and a 15% difference between study arms determined the need for 374 patients. An interim analysis was conducted when data were available for 200 subjects., Results: Four hundred twenty patients were approached for participation. Two hundred eight eligible patients consented to participate and were randomized. At the planned interim analysis, the data and safety monitoring board recommended that the study be halted for futility. Baseline characteristics were comparable between the groups. Fourteen percent (29/208) of the sample reported allergic symptoms. Of patients randomized to diphenhydramine, 40% (40/100) reported sustained relief at 48 hours, as did 37% (38/103) of patients randomized to placebo (95% confidence interval [CI] for difference of 3%: -10% to 16%). One hour after medication administration, patients randomized to diphenhydramine improved by a mean of 5.1 on the 0 to 10 scale versus 4.8 for those randomized to placebo (95% CI for difference of 0.3: -0.6 to 1.1). Eighty-five percent (84/99) of the patients in the diphenhydramine arm reported they would want the same medication combination during a subsequent ED visit, as did 76% (77/102) of those who received placebo (95% CI for difference of 9%: -2% to 20%). Median ED length of stay was 122 minutes (interquartile range 84 to 180 minutes) in the diphenhydramine group and 139 minutes (interquartile range 90 to 235 minutes) in the placebo arm. Rates of adverse effects, including akathisia, were comparable between the groups., Conclusion: Intravenous diphenhydramine, when administered as adjuvant therapy with metoclopramide, does not improve migraine outcomes., (Copyright © 2016 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Study Objective: We compare a high initial dose of 2 mg intravenous hydromorphone against titration of 1 mg intravenous hydromorphone followed by an optional second dose., Methods: Patients aged 21 to 64 years with severe pain were randomly allocated to 2 mg intravenous hydromorphone in a single bolus or the "1+1" hydromorphone titration protocol. 1+1 Patients received 1 mg intravenous hydromorphone followed by a second 1 mg dose 15 minutes later if they answered yes when asked, Do you want more pain medication? The primary outcome was the between-group difference in proportion of patients who declined additional analgesia at 60 minutes., Results: Of the 350 enrolled patients, 334 had sufficient data for analysis. The proportion who declined additional analgesics was 67.5% in the 2 mg bolus arm and 67.3% in the 1+1 titration arm (difference 0.2%; 95% confidence interval -9.7% to 10.2%). The between-group difference in numeric rating scale pain scores was 0.4 numeric rating scale units (95% confidence interval -0.3 to 1.1). The incidence of adverse effects was similar; 42.3% of 1+1 patients achieved satisfactory analgesia at 1 hour with only 1 mg hydromorphone., Conclusion: A hydromorphone 1+1 titration protocol provides similar pain relief to an initial 2 mg bolus dose, with no apparent clinical advantage to the latter. The 1+1 titration protocol had an opioid-sparing effect because 50% less opioid was needed to achieve satisfactory analgesia for 42.3% of patients allocated to this protocol., (Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.)

Study Objective: We compare metoclopramide 20 mg intravenously, combined with diphenhydramine 25 mg intravenously, with ketorolac 30 mg intravenously in adults with tension-type headache and all nonmigraine, noncluster recurrent headaches., Methods: In this emergency department (ED)-based randomized, double-blind study, we enrolled adults with nonmigraine, noncluster recurrent headaches. Patients with tension-type headache were a subgroup of special interest. Our primary outcome was a comparison of the improvement in pain score between baseline and 1 hour later, assessed on a 0 to 10 verbal scale. We defined a between-group difference of 2.0 as the minimum clinically significant difference. Secondary endpoints included need for rescue medication in the ED, achieving headache freedom in the ED and sustaining it for 24 hours, and patient's desire to receive the same medication again., Results: We included 120 patients in the analysis. The metoclopramide/diphenhydramine arm improved by a median of 5 (interquartile range 3, 7) scale units, whereas the ketorolac arm improved by a median of 3 (IQR 2, 6) (95% confidence interval [CI] for difference 0 to 3). Metoclopramide+diphenhydramine was superior to ketorolac for all 3 secondary outcomes: the number needed to treat for not requiring ED rescue medication was 3 (95% CI 2 to 6); for sustained headache freedom, 6 (95% CI 3 to 20); and for wish to receive the same medication again, 7 (95% CI 4 to 65). Tension-type headache subgroup results were similar., Conclusion: For adults who presented to an ED with tension-type headache or with nonmigraine, noncluster recurrent headache, intravenous metoclopramide+diphenhydramine provided more headache relief than intravenous ketorolac., (Copyright © 2013 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.)

Study Objective: Nearly 3 million patients present to US emergency departments (EDs) annually with undifferentiated musculoskeletal low back pain. Little is known about short- and longer-term outcomes in this group. We seek to describe the pain and functional outcomes 1 week and 3 months after discharge in a sample of ED patients presenting with undifferentiated musculoskeletal low back pain., Methods: We used a prospective observational descriptive cohort design, enrolling ED patients with a chief complaint of low back pain classified as musculoskeletal in origin by the ED attending physician. We defined low back pain as pain originating in the posterior back between the tips of the scapulae and upper buttocks and excluded any patient with a traumatic back injury occurring within the previous month. We interviewed patients in the ED and then by telephone follow-up 1 week and 3 months after ED discharge, using a scripted closed-question data collection instrument. Our primary outcome was functional limitation attributable to low back pain assessed with a validated scale. Secondary outcomes included pain and analgesic use during the 24 hours before each follow-up telephone call., Results: During a 9-month period beginning in July 2009, we approached 894 patients, of whom 556 were enrolled. We obtained follow-up on 97% of our sample at 1 week and 92% at 3 months. One week after ED discharge, 70% (95% confidence interval [CI] 66% to 74%) of patients reported back pain-related functional impairment, 59% (95% CI 55% to 63%) reported moderate or severe low back pain, and 69% (95% CI 65% to 73%) reported analgesic use within the previous 24 hours. Three months after ED discharge, 48% (95% CI 44% to 52%) of patients reported functional impairment, 42% (95% CI 38% to 46%) reported moderate or severe pain, and 46% (95% CI 44% to 50%) reported analgesic use within the previous 24 hours., Conclusion: There is substantial short- and longer-term morbidity and ongoing analgesic use among patients who present to an ED with undifferentiated musculoskeletal low back pain., (Copyright © 2011. Published by Mosby, Inc.)

Study Objective: We test the efficacy and safety of the "1+1" (1 mg plus 1 mg 15 minutes later if needed) hydromorphone protocol against usual care of emergency department (ED) patients with acute severe pain., Methods: This was a prospective, randomized clinical trial of ED patients with acute severe pain. The 1+1 protocol specifies administration of 1 mg intravenous hydromorphone, followed by a second dose of 1 mg intravenous hydromorphone 15 minutes after the first bolus if the patient answers yes to the question, "Do you want more pain medication?" Usual care is the administration of any intravenous opioid, with type and dose chosen by the ED attending physician. Usual care patients who wanted more medication at 15 minutes were treated at the physician's discretion. At 60 minutes, all patients were asked again whether they wanted more pain medication. The primary outcome was successful treatment defined a priori as not wanting additional analgesia at either 15 or 60 minutes after the initial bolus. The primary endpoint was the difference in the proportion of patients with successful treatment who received the complete 1+1 protocol versus usual care with a per-protocol analysis. An intention-to-treat analysis was also performed. A 10% difference in rate of successful treatment was chosen a priori as a clinically meaningful difference., Results: Of 167 patients in the 1+1 group, 156 received the full 1+1 protocol, whereas 171 received usual care. Of patients who received the 1+1 protocol, 92.3% (144/156) had successful treatment versus 76.6% (131/171) of usual care patients (difference=15.7%; 95% confidence interval 7.9% to 23.3%). In the intention-to-treat analysis, 86.8% (145/167) of patients randomized to the 1+1 group received successful treatment versus 76.6% (131/171) of usual care patients (difference=10.2%; 95% confidence interval 2.0% to 18.3%). No patient required naloxone. One patient in the 1+1 group and 2 patients in the usual care group had transient oxygen saturation less than 95%. The incidence of all adverse effects was similar in both groups., Conclusion: When analyzed per protocol or with the more conservative intention-to-treat analysis, the 1+1 hydromorphone protocol is statistically and clinically more efficacious than usual care. Safety profiles were similar in both groups., (Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.)

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., (Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.)

Study Objective: To identify the minimum clinically significant difference in pain in elderly emergency department (ED) patients., Methods: This was an observational, prospective study of a convenience sample of patients aged 65 years or older with acute pain. Patients rated their pain on an 11-point numeric rating scale (NRS) on entering the study and every 30 minutes for 2 hours. The arithmetic minimum clinically significant difference was defined as the mean difference between current and preceding NRS scores when the subject described his or her pain as "a little less pain" or "a little more pain." The proportional minimum clinically significant difference was change in NRS in a 30-minute interval divided by the NRS at the beginning of the interval. We used generalized estimating equations to adjust for nonindependence of pain scores and to test trend over time., Results: One hundred ninety-five patients were enrolled (mean age 74 years; 73% women; 51% Hispanic; 33% black). The arithmetic minimum clinically significant difference averaged over all periods was 1.5 (95% confidence interval 1.3 to 1.6), the proportional minimum clinically significant difference was 25% (95% confidence interval 20% to 29%). The arithmetic minimum clinically significant difference unexpectedly decreased over time: 2.1 from baseline to 30 minutes, 1.4 from 30 to 60 minutes, 1.3 from 60 to 90 minutes, and 1.0 from 90 to 120 minutes (P<.001). In contrast, the proportional differences were more stable: 27% from baseline to 30 minutes, 22% from 30 to 60 minutes, 22% from 60 to 90 minutes, and 28% from 90 to 120 minutes (P=.89)., Conclusion: The arithmetic minimum clinically significant difference in older ED patients was 1.5 NRS units and decreased over time, whereas the proportional change was 25% and more stable., (Copyright © 2009 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.)

Study Objective: Multiple parenteral medications are used to treat migraine and other acute primary headaches in the emergency department (ED). Regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of primary headache after ED discharge. It is uncertain which medication primary headache patients should be given on discharge from an ED. The aim of this study is to compare the efficacy of oral sumatriptan with naproxen for treatment of post-ED recurrent primary headache., Methods: This was a randomized, double-blind efficacy trial. We randomized patients to either naproxen 500 mg or sumatriptan 100 mg for headache recurrence after ED discharge. Patients were eligible if they received parenteral therapy for an acute exacerbation of a primary headache in the ED. Patients who met established criteria for migraine without aura were designated a priori as a homogenous subgroup of interest. We followed all patients by telephone 48 hours after ED discharge. The primary endpoint was the between-group difference in change in pain intensity during the 2-hour period after ingestion of either 500 mg naproxen or 100 mg sumatriptan. This difference was measured on a validated 11-point (0 to 10) verbal numeric rating scale (NRS). Satisfaction with the medication and adverse effects were also assessed. Patients who met criteria for migraine without aura were analyzed twice according to a priori design: once as a homogenous subgroup and then again combined with all other primary headaches., Results: Of 410 patients randomized, 383 (93%) had outcome data available for analysis. Two hundred eighty (73%; 95% confidence interval [CI] 68% to 77%) reported headache post-ED discharge and 196 (51%; 95% CI 44% to 58%), including 88 with migraine, took the investigational medication provided to them. The naproxen group improved by a mean of 4.3 NRS points, whereas the sumatriptan group improved by 4.1 points (95% CI for difference of 0.2 points: -0.7 to 1.1 points). Findings were virtually identical among the migraine subset (4.3 versus 4.2 NRS points; 95% CI for difference of 0.1 points: -1.3 to 1.5 points). Seventy-one percent (95% CI 62% to 80%) of naproxen patients and 75% (95% CI 66% to 84%) of sumatriptan patients would want to take the same medication the next time. Adverse effect profiles were also comparable., Conclusion: In this trial, nearly three quarters of patients reported headache recurrence within 48 hours of ED discharge. Naproxen 500 mg and sumatriptan 100 mg taken orally relieve post-ED recurrent primary headache and migraine comparably. Clinicians should be guided by medication costs, contraindications, and a patient's previous experience with the medication., (Copyright 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.)

Study Objective: We test the null hypothesis that the "1+1" hydromorphone patient-driven protocol is clinically and statistically equivalent in safety and efficacy to that of traditional physician-driven administration of opioids for emergency department (ED) treatment of acute severe pain., Methods: This was a prospective randomized clinical trial of nonelderly adults presenting to an urban academic ED with acute pain of sufficient severity to warrant intravenous (IV) opioids in the judgment of the attending physician. Patients randomized to the 1+1 hydromorphone patient-driven protocol received 1 mg IV hydromorphone followed by a second 1-mg dose 15 minutes later if the patient responded affirmatively to the question, "Do you want more pain medication?" Patients in the physician-driven group received any IV opioid in the dose chosen by the ED attending physician, with any additional analgesia provided at the discretion of that physician. The primary outcome was the difference in improvement in pain between the 2 groups at 60 minutes, as measured by a validated and reproducible numeric rating scale. Secondary outcomes included incidence of oxygen desaturation, hypoventilation, hypotension, bradycardia, nausea, vomiting, pruritus, and use of naloxone., Results: The mean decrease in numeric rating scale pain scores for the 1+1 hydromorphone patient-driven group was 5.6 versus 4.5 in the physician-driven group. The difference of 1.1 numeric rating scale units (95% confidence interval 0.3 to 1.9) was statistically significant but fell 0.2 numeric rating scale units short of the 1.3 numeric rating scale unit threshold required to attain clinically significant efficacy. Safety profiles were similarly satisfactory in both groups. Ninety-four percent of the 1+1 hydromorphone patient-driven group achieved adequate analgesia (as defined by the patient) within 60 minutes of protocol initiation., Conclusion: The 1+1 hydromorphone patient-driven protocol is statistically superior and at least as clinically efficacious and safe as traditional physician-driven treatment of ED patients with acute severe pain. More than 9 of 10 patients randomized to the study protocol achieved satisfactory pain control, as defined by the patient, within an hour or less.

Study Objective: We evaluate the safety and efficacy of a pain protocol using 1 mg intravenous (IV) hydromorphone followed by an optional dose of 1 mg IV hydromorphone 15 minutes later., Methods: Prospective interventional study at an urban academic emergency department (ED). One milligram of IV hydromorphone was administered to adults 21 to 64 years of age who had acute severe pain. Fifteen minutes later, patients were asked whether they wanted more pain medication. If they answered yes, they received another 1 mg of IV hydromorphone and were again asked 15 minutes later whether they wanted more pain medication. The primary efficacy outcome was the proportion of patients who had adequate analgesia, defined as declining additional hydromorphone within 1 hour of entering the protocol. The primary safety outcome was incidence of oxygen desaturation less than 95%. Secondary outcomes included numeric rating scale pain scores and adverse events., Results: Of the 223 patients with complete data, 1 mg IV hydromorphone provided adequate analgesia for 77% (95% confidence interval 71% to 82%) within 15 minutes and 96% (95% confidence interval 92% to 98%) within 1 hour of entering the protocol. Eighty-six percent of patients reported pain scores that decreased by 2 or more numeric rating scale units. Five percent experienced transient oxygen desaturation below 95%, which was corrected promptly with oxygen., Conclusion: A rapid titration protocol using IV hydromorphone (1 mg hydromorphone followed by an optional 1 mg 15 minutes later) is efficacious in nonelderly ED patients with acute severe pain. There were no serious adverse events.

Study Objective: Akathisia, an adverse effect observed at times after administration of parenteral metoclopramide, is an unpleasant symptom complex characterized by restlessness and agitation. Some try to limit the development of akathisia by coadministering diphenhydramine when using parenteral metoclopramide. The goal of this investigation is to determine whether concomitant administration of diphenhydramine 25 mg decreased the rate of development of akathisia after administration of 10 mg or 20 mg of intravenous metoclopramide., Methods: This was a randomized, double-blind, factorial design trial. Patients who presented to our emergency department with a primary or secondary chief complaint of nausea were randomized to one of the following 4 groups: (1) metoclopramide 10 mg+diphenhydramine 25 mg; (2) metoclopramide 10 mg+placebo; (3) metoclopramide 20 mg+diphenhydramine 25 mg; (4) metoclopramide 20 mg+placebo. The medications were inserted into a 50-mL bag of normal saline solution and administered as an intravenous drip during 15 minutes. Primary outcome was development of akathisia within 60 minutes of medication administration, as measured by blinded assessors using a short akathisia instrument, or use of rescue medication for treatment of akathisia by blinded clinical staff. Patients were also asked at baseline and 30 minutes later whether they felt restless., Results: Two hundred eighty-nine patients were randomized and 286 patients were included in the final analysis. Within 1 hour of medication administration, 17 of 143 patients randomized to diphenhydramine (12%; 95% confidence interval [CI] 8% to 18%) and 17 of 143 (12%; 95% CI 8% to 18%) randomized to placebo developed akathisia (95% CI for difference of 0%: -8% to 8%). Thirteen of 143 patients randomized to metoclopramide 10 mg (9%; 95% CI 5% to 15%) and 21 of 143 randomized to metoclopramide 20 mg (15%; 95% CI 10% to 22%) developed akathisia (95% CI for difference of 6%: -2% to 14%). In those administered prophylactic diphenhydramine, odds of akathisia relative to placebo were 1.0 (95% CI 0.5 to 2.0). Odds of akathisia in those administered 20 mg of metoclopramide relative to the 10-mg dose were 1.7 (95% CI 0.8 to 3.6). Among patients who received 20 mg of metoclopramide, subjective restlessness was reported by 7 of 72 (9.7%) patients who received diphenhydramine and 14 of 71 (19.7%) patients who received placebo (95% CI for difference of 10%: -2% to 22%)., Conclusion: Routine prophylaxis with diphenhydramine to prevent akathisia is unwarranted when intravenous metoclopramide is administered over 15 minutes. For patients administered 20 mg of metoclopramide, prophylactic diphenhydramine may decrease subjective restlessness.

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.

Study Objective: We compare prochlorperazine 10 mg intravenously versus metoclopramide 20 mg intravenously for the emergency department (ED) treatment of acute migraine., Methods: This was a randomized, double-blind, clinical trial comparing 2 parenteral dopamine antagonists. Both drugs were administered during 15 minutes with 25 mg intravenous diphenhydramine. Pain scores on a numeric rating scale were assessed at baseline, every 30 minutes for 2 hours, and by telephone 24 hours after discharge. The primary endpoint was the between-group difference in change in numeric rating scale from baseline to 1 hour postbaseline. Secondary endpoints included mean differences in change in numeric rating scale at 2 and 24 hours, headache relief, adverse effects, and desire to receive the same treatment for future migraines., Results: Of 152 patients screened, 97 were eligible and 77 were randomized. The mean change in numeric rating scale scores at 1 hour was 5.5 and 5.2 in subjects receiving prochlorperazine and metoclopramide, respectively (difference=0.3; 95% confidence interval [CI] -1.0 to 1.6). Findings were similar at 2 hours and 24 hours. Forty-six percent (18/39) of prochlorperazine and 32% (12/38) of metoclopramide subjects reported adverse events (difference=15%; 95% CI -6% to 36%). Seventy-seven percent (26/34) of prochlorperazine and 73% (27/37) of metoclopramide subjects wanted to receive the same medication in future ED visits (difference=4%; 95% CI -16% to 24%)., Conclusion: Either prochlorperazine 10 mg intravenously or metoclopramide 20 mg intravenously, combined with diphenhydramine 25 mg intravenously, is an efficacious treatment for ED patients with acute migraine. Three quarters of subjects in both arms would want the same medication for their next migraine.

Study Objective: We conduct a prospective independent validation of the San Francisco Syncope Rule to identify emergency department (ED) syncope patients with short-term serious outcomes., Methods: This was a prospective observational cohort study of adult patients presenting to a university hospital ED with acute syncope or near syncope. Patients meeting inclusion criteria as defined in the San Francisco Syncope Rule derivation were evaluated for 5 previously derived predictor variables: abnormal ECG result, shortness of breath, hematocrit level less than 30%, triage systolic blood pressure less than 90 mm Hg, and history of congestive heart failure. Hospital admission occurred at the discretion of the emergency physician, independent of the decision rule. Follow-up occurred through contact with the inpatient attending physician for admitted patients and by telephone contact with patients not hospitalized or those hospitalized and discharged before day 7. Predetermined outcome measures as defined by the San Francisco Syncope Rule were death, myocardial infarction, arrhythmia, pulmonary embolism, stroke, subarachnoid hemorrhage, significant hemorrhage, or any condition causing or likely to cause a return ED visit and hospitalization for a related event., Results: Complete predictor and follow-up data were available for 713 of 743 (96%) enrolled patients. Sixty-one of 713 (9%) patients met predetermined criteria for serious outcome. Sixteen of 61 (26%; 95% confidence interval [CI] 16% to 39%) patients with a serious outcome were not identified as high risk by the rule. Rule performance to predict serious outcomes was sensitivity 74% (95% CI 61% to 84%), specificity 57% (95% CI 53% to 61%); negative likelihood ratio 0.5 (95% CI 0.3 to 0.7) and positive likelihood ratio 1.7 (95% CI 1.4 to 2.0)., Conclusion: In this independent validation study, sensitivity and negative likelihood ratio of the San Francisco Syncope Rule were substantially lower than reported in the original studies and suggest that the rule has limited generalizability.

Study Objective: Although almost 2 decades have passed since the International Headache Society first introduced its International Classification of Headache Disorders (ICHD), the applicability of this classification scheme in the emergency department (ED) has not been assessed. As a first step toward identifying the role the ICHD should play in the ED, we address 2 questions: Can a structured interview and adherence to the ICHD allow ED headache patients to be classified in a reproducible manner? With the ICHD, how often can one specific diagnosis be assigned to each ED headache presentation?, Methods: This was a structured interview and medical record review of patients with nontraumatic headache, performed in an urban ED from March 2004 through August 2005. Using the data from the interview and the subject's ED record, 2 emergency medicine investigators independently classified each of the headaches twice: first, to determine presence or absence of a primary headache disorder, and then to determine presence or absence of a secondary headache disorder. If a primary headache was present, it was further classified as migraine, tension-type headache, trigeminal autonomic cephalalgia, chronic daily headache, or primary headache unclassifiable. Interobserver discordance was adjudicated by an experienced headache specialist., Results: Four hundred eighty patients were enrolled in the study. The emergency medicine investigators had a high level of interobserver agreement on secondary headaches (agreement 94% [95% confidence interval (CI) 92% to 96%]) and primary headaches (agreement 91% [95% CI 88% to 93%]). Among the 480 subjects, 122 (25%) had a secondary headache disorder, 309 (64%) had a primary headache disorder, 49 (10%) had a coexisting primary and secondary headache, and for 95 (20%) subjects, neither a primary nor a secondary headache could be diagnosed. Of 309 subjects with a primary headache, 186 (60%) had migraine, 34 (11%) had tension-type headache, 2 (1%) had trigeminal autonomic cephalalgia, and 77 (26%) had an unclassifiable primary headache. Overall, a specific ICHD headache diagnosis could not be assigned to 36% of subjects either because a specific primary headache disorder could not be identified or because neither a primary nor a secondary headache disorder could be diagnosed., Conclusion: Although a detailed structured interview in the ED and adherence to the ICHD resulted in reproducible classification of headache patients, more than one third of acute headache patients could not readily be given a specific ICHD diagnosis in the ED.

Study Objective: We compare pain relief and safety of morphine 0.10 mg/kg with 0.15 mg/kg in adult emergency department (ED) patients with acute pain., Methods: This was a randomized double-blind placebo-controlled trial of intravenous morphine 0.10 mg/kg versus 0.15 mg/kg, (delivered in 2 divided doses) in adult ED patients with acute pain requiring opioid analgesia. Assessment was made at baseline, 30 minutes, and 60 minutes with a validated verbal numeric rating scale. Pain reduction and satisfaction scores were measured at 30 and 60 minutes. The primary outcome measure was the between-group difference in mean before-after change in numeric rating scale from baseline to 60 minutes., Results: Two hundred eighty patients were enrolled. Between-group difference in numeric rating scale improvement from baseline to 60 minutes was 0.8 (95% confidence interval 0.1 to 1.5), favoring the 0.15 mg/kg group. Pain relief scores and adverse events were similar in the 2 groups., Conclusion: Although 0.15 mg/kg of morphine is safe and provides statistically superior analgesia compared with a dose of morphine at 0.10 mg/kg, this difference in pain reduction did not reach the threshold of greater than 1.3 numeric rating scale units required to declare the higher dose of morphine clinically superior.

Study Objective: Administration of analgesia to patients with acute abdominal pain is controversial. We test the hypothesis that morphine given to emergency department (ED) patients with acute abdominal pain will reduce discomfort and improve clinically important diagnostic accuracy., Methods: Pain was measured with a standard 0- to 100-mm visual analog scale. ED patients with acute abdominal pain were randomized in a double-blind fashion to 0.1 mg/kg intravenous morphine or placebo. The primary endpoint was the difference between the 2 study arms in clinically important diagnostic accuracy. Clinically important diagnostic accuracy was defined a priori by its complement, clinically important diagnostic error, using 2 independent, blinded investigators to identify any discordance between the provisional and final diagnoses that might adversely affect the patient's health status. The provisional diagnosis was provided by an ED attending physician, who examined the patient only once, 15 minutes after administration of the study agent. The final diagnosis was obtained through follow-up at least 6 weeks after the index ED visit., Results: We randomized 160 patients, of whom 153 patients were available for analysis, 78 patients in the morphine group and 75 patients in the placebo group. Baseline features were similar in both groups, including initial median visual analog scale scores of 98 mm and 99 mm. The median decrease in visual analog scale score at 15 minutes was 33 mm in the morphine group and 2 mm in the placebo group. There were 11 instances of diagnostic discordance in each group, for a clinically important diagnostic accuracy of 86% (67/78) in the morphine group and 85% (64/75) in the placebo group. The difference in clinically important diagnostic accuracy between the 2 groups was 1% (95% confidence interval [CI] -11% to 12%). Analysis by efficacy and intention to treat yielded similar results. Kappa for interobserver concordance in classification of clinically important diagnostic accuracy was 0.94 (95% CI 0.79 to 1.00). No patients required naloxone., Conclusion: Although administration of intravenous morphine to adult ED patients with acute abdominal pain could lead to as much as a 12% difference in diagnostic accuracy, equally favoring opioid or placebo, our data are most consistent with the inference that morphine safely provides analgesia without impairing clinically important diagnostic accuracy.

Study Objective: We compare a standard weight-based dose of intravenous hydromorphone (Dilaudid) to a standard weight-based dose of intravenous morphine in adults presenting to the ED with acute severe pain., Methods: This was a prospective, randomized, double-blind, clinical trial conducted in an academic medical center. Of the 198 adult patients presenting to the ED with acute severe pain who were randomized to receive either intravenous hydromorphone at 0.015 mg/kg or intravenous morphine at 0.1 mg/kg, 191 patients had sufficient data for analysis. The main outcome measure was the difference between the 2 groups in pain reduction at 30 minutes as measured on a validated numeric rating scale. Adverse effects, pain reduction at 5 minutes and 2 hours postbaseline, and additional analgesics and antiemetics were tracked as secondary outcome measures., Results: The mean change of pain from baseline to 30 minutes postbaseline in patients allocated to intravenous hydromorphone was -5.5 numeric rating scale units versus -4.1 in patients allocated to intravenous morphine (difference -1.3; 95% confidence interval -2.2 to -0.5). Adverse effects were similar in both groups, with the exception of pruritus, which did not occur in patients receiving hydromorphone (0% versus 6% [difference -6%; 95% confidence interval -11% to -1%]). No patient required naloxone., Conclusion: For the treatment of acute, severe pain in the emergency department, intravenous hydromorphone at 0.015 mg/kg represents a feasible alternative to intravenous morphine at 0.1 mg/kg.

Study Objective: We examine the concordance between end-tidal partial pressure of CO2 (PetCO2) measured by capnography and arterial partial pressure of carbon dioxide (PaCO2) obtained by arterial blood gas in acute asthmatic patients presenting to the emergency department., Methods: This was a prospective observational cohort study of acutely ill adult asthmatic patients undergoing an arterial blood gas measurement as part of their evaluation. PetCO2 was recorded during exhalation into a capnograph while arterial blood was pulsing in the arterial blood gas tubing. Concordance between PetCO2 and PaCO2 was displayed as a Bland-Altman matrix, using prespecified limits of agreement of +/-5 mm Hg difference between PetCO2 and PaCO2 in each patient., Results: The mean difference between the PetCO2 and PaCO2 levels was 1.0 mm Hg (95% confidence interval -0.1 to 2.0 mm Hg), with a median of 0 mm Hg. Of the 39 patients enrolled, 37 (95%) fell within the a priori limits of agreement., Conclusion: In adult asthmatic patients with acute exacerbations, concordance between PetCO2 measured by capnography and PaCO2 measured by arterial blood gas was high. These findings must be validated before capnography replacement of arterial blood gas as an accurate means of assessing alveolar ventilation in acute asthma is recommended.

Study Objective: The objective was to quantify the analgesic effect of a dose of intravenous morphine, 0.1 mg/kg, to emergency department (ED) patients presenting in acute, severe pain., Methods: This was a prospective convenience cohort of patients aged 21 to 65 years and presenting to an academic urban ED with acute, severe pain. Patients rated their pain intensity on a validated 11-point verbal numeric rating scale ranging from 0, "no pain," to 10, "worst possible pain," immediately before they received 0.1 mg of intravenous morphine per kilogram of body weight and 30 minutes later. The main outcome was proportion of patients whose pain decreased by less than 50% during the 30-minute interval., Results: Of 119 patients who received intravenous morphine at 0.1 mg/kg, the average age was 42 years (SD=11 years), 55% were female patients, 65% were Hispanic, 28% were black, and 7% were classified as other. The median numeric rating scale pain score at baseline was 10 (interquartile range 9 to 10). Sixty-seven percent (95% confidence interval 58% to 76%) of the patients receiving intravenous morphine at 0.1 mg/kg reported a less than 50% decrease in pain. No patient required an opioid antagonist at any time during or after the study period., Conclusion: The data suggest that a 0.1 mg/kg dose of morphine may be too low to adequately control acute severe pain.

In Williamsburg, VA, April 17 to 20, 1994, the Josiah Macy, Jr. Foundation sponsored a conference entitled "The Role of Emergency Medicine in the Future of American Medical Care," a report on which was published in Annals in 1995. This report promulgated recommendations for the development and enhancement of academic departments of emergency medicine and a conference to develop an agenda for research in emergency medicine. The American College of Emergency Physicians' Research Committee, along with several ad hoc members, presents updates in several of the areas addressed by the Macy Report and subsequent conferences, as a status report for the development of emergency medicine research as a whole, as of late 2002.

Study Objective: One of the principal criticisms of performance assessments, particularly those using an oral format to evaluate physician performance, is the lack of interrater reliability. The objective of this study was to assess interexaminer agreement in the scoring of candidates taking the American Board of Emergency Medicine (ABEM) oral certification examination., Methods: Examiner-observer pairs independently scored individual candidates on each of the 6 simulated cases selected for the October 1999 examination. Simple proportionate agreement for "acceptable" and "unacceptable" scores on critical actions and performance ratings were used to measure interexaminer (examiner-observer) agreement. Further analyses were performed to assess interexaminer agreement at the level of the raw scores of all performance ratings. The candidate's actual score was determined entirely by the examiner administering the case. The study examiner was present only to observe and independently score the candidate. Examiners were blinded to each other's scoring. All examiner-observer, examiner-candidate, and observer-candidate pairings were uniquely randomized and occurred only once during the examination., Results: Of 564 candidates, 186 were randomly selected for scoring by examiner-observer pairs drawn from a pool of 107 trained oral examiners. Interexaminer agreement for 47 critical actions was 97% (95% confidence interval [CI] 96% to 98%), and interexaminer agreement for 68 performance ratings was 95% (95% CI 94% to 96%). Further analyses of raw scores of performance ratings indicated that 94% (95% CI 93% to 95%) of 2,648 pairs of ratings differed by 1 point or less., Conclusion: High interexaminer agreement on the scoring of the ABEM oral certification examination supports the reliability of this final step in the certification process. On the basis of these findings, ABEM has incorporated this methodology into the administration of each oral examination as an ongoing quality control measure.

The American Board of Emergency Medicine gathers extensive background information on emergency medicine residents and the programs in which they train. We present the sixth annual report on the status of US emergency medicine residency programs.

The American Board of Emergency Medicine gathers extensive background information on emergency medicine residents and the programs in which they train. We present the fifth annual report on the status of US emergency medicine residency programs

Study Objective: The study was undertaken to determine whether pain perception is different in elderly patients than in younger patients., Methods: A cross-sectional, observational study was conducted at 2 urban academic emergency departments. Adult patients (> or =18 years of age) who required an 18-gauge intravenous catheter as part of their ED care were eligible. Patients were excluded for the following conditions: more than one attempt at intravenous catheter placement, altered mental status, visual impairment, intoxication, distracting pain, or abnormal upper extremities. Patients were asked to indicate on a 10-cm visual analog scale (VAS) the amount of pain they had at baseline immediately before intravenous catheter placement. They were then asked to indicate on a separate VAS the amount of pain caused by intravenous catheter placement. Patients aged 65 years and older were defined a priori as elderly., Results: Of 100 patients enrolled in the study, 32 (32%) were elderly. Elderly patients reported significantly less pain than nonelderly patients (Delta = -15 mm, 95% confidence interval -26 to -4 mm). Pain of intravenous catheter placement was not associated with sex, baseline pain, site of intravenous catheter insertion, or level of training of the individual placing the intravenous catheter., Conclusion: Elderly patients experienced less acute pain than their younger counterparts in response to a standardized stimulus in a clinical setting. This difference is both statistically and clinically significant. This may have clinical implications for the assessment and treatment of acute pain in the elderly.

Background: In a landmark hypothesis-generating study, Todd et al found that a difference of approximately 13 mm (95% confidence interval [CI] 10 to 17 mm) on a visual analog scale (VAS) represented the minimum change in acute pain that was clinically significant in a cohort of trauma patients., Study Objective: We test the hypothesis that the minimum clinically significant change in pain as measured by the VAS in an independent, more heterogeneous validation cohort is approximately 13 mm., Methods: This was a prospective, observational cohort study of adults presenting to 2 urban emergency departments with pain. At 30-minute intervals during a 2-hour period, patients marked a VAS and were asked if their pain was "much less," "a little less," "about the same," "a little more," or "much more." All data were obtained without reference to prior VAS scores. The minimum clinically significant change in pain was defined a priori as the difference in millimeters between the current and immediately preceding VAS scores when "a little more" or "a little less pain" was reported., Results: Ninety-six patients enrolled in the study, providing 332 paired pain measurements. There were 141 paired measurements designated by patients as "a little less" or "a little more" pain. The mean clinically significant difference between consecutive ratings of pain in the combined "little less" or "little more" groups was 13 mm (95% CI 10 to 16 mm). The difference between this finding and that of Todd et al was 0 mm (95% CI -4 to 4 mm)., Conclusion: These data are virtually identical to previous findings indicating that a difference of 13 mm on a VAS represents, on average, the minimum change in acute pain that is clinically significant.

Study Objective: We test the hypothesis that intravenous magnesium sulfate is an effective adjunctive medication for treatment of acute migraine., Methods: In this randomized, double-blind, placebo-controlled trial, adults presenting to 2 urban emergency departments with headache meeting International Headache Society criteria for acute migraine received either 20 mg of intravenous metoclopramide plus 2 g of intravenous magnesium sulfate or 20 mg of intravenous metoclopramide plus a placebo of intravenous saline solution at 15-minute intervals for a maximum of 3 doses or until pain relief occurred. At 0, 15, 30, and 45 minutes, patients recorded pain intensity using a standard visual analog scale (VAS). The primary study end point was the between-group difference in pain improvement when initial and final VAS scores were compared., Results: Of 44 patients enrolled (21 randomized to metoclopramide plus magnesium and 23 to metoclopramide plus placebo), 42 (95%) were women. Baseline features were comparable in both groups. Each group experienced a more than 50-mm improvement in VAS score during the study. However, this improvement was smaller in the magnesium group for the primary end point (16-mm difference favoring placebo [95% confidence interval (CI) -2 to 34 mm]), as was the proportion with normal functional status at their final rating (36% absolute difference also favoring placebo [95% CI 7% to 65%]). Using a 50% reduction in pain to dichotomize VAS scores, the number needed to harm with magnesium plus metoclopramide versus metoclopramide alone is 4 patients (95% CI 2 to 36)., Conclusion: Although this result was unexpected, our data suggest that the addition of magnesium to metoclopramide may attenuate the effectiveness of metoclopramide in relieving migraine. Countertherapeutic cerebral vasodilatation caused by magnesium is a plausible, although unproven, explanation for this finding. Because of the preponderance of women in our trial, these data may not be generalizable to men.