Magnesium Sulfate Versus Lidocaine as an Adjunct for Renal Colic in the Emergency Department: A Randomized, Double-Blind Controlled Trial.

STUDY OBJECTIVE: We wished to determine whether the addition of magnesium sulfate (MgSO4) or lidocaine to diclofenac could improve the analgesic efficacy in emergency department (ED) patients with acute renal colic. METHODS: In this prospective, double-blinded, randomized controlled trial of patients aged 18 to 65 years with suspected acute renal colic, we randomized them to receive 75 mg intramuscular (IM) diclofenac and then intravenous (IV) MgSO4, lidocaine, or saline solution control. Subjects reported their pain using a numerical rating scale (NRS) before drug administration and then 5, 10, 20, 30, 60, and 90 minutes afterwards. Our primary outcome was the proportion of participants achieving at least a 50% reduction in the NRS score 30 minutes after drug administration. RESULTS: We enrolled 280 patients in each group. A 50% or greater reduction in the NRS score at 30 minutes occurred in 227 (81.7%) patients in the MgSO4 group, 204 (72.9%) in the lidocaine group, and 201 (71.8%) in the control group, with significant differences between MgSO4 and lidocaine (8.8%, 95% confidence interval [CI] [1.89 to 15.7], P=.013) and between MgSO4 and control (9.9%, 95% CI [2.95 to 16.84], P=.004). Despite this, differences between all groups at every time point were below the accepted 1.3 threshold for clinical importance. There were no observed differences between groups in the frequency of rescue analgesics and return visits to the ED for renal colic. There were more adverse events, although minor, in the MgSO4 group. CONCLUSION: Adding intravenous MgSO4, but not lidocaine, to IM diclofenac offered superior pain relief but at levels below accepted thresholds for clinical importance.

Twice-Daily Oral Zinc in the Treatment of Patients With Coronavirus Disease 2019: A Randomized Double-Blind Controlled Trial.

BACKGROUND: Zinc supplementation has been considered a potential therapy for coronavirus disease 2019 (COVID-19). We aimed to examine zinc efficacy in adult patients with COVID-19 infection. METHODS: We conducted a prospective, randomized, double-blind, placebo-controlled multicenter trial. Patients who were tested positive for COVID-19 without end-organ failure were randomized to oral zinc (n = 231) or matching placebo (n = 239) for 15 days. The primary combined outcome was death due to COVID-19 or intensive care unit (ICU) admission ≤30 days after randomization. Secondary outcomes included length of hospital stay for inpatients and duration of COVID-19 symptoms with COVID-19-related hospitalization for outpatients. RESULTS: 190 patients (40.4%) were ambulatory and 280 patients (59.6%) were hospitalized. Mortality at 30 days was 6.5% in the zinc group and 9.2% in the placebo group (OR: .68; 95% CI .34-1.35); ICU admission rates were, respectively, 5.2% and 11.3% (OR: .43; 95% CI .21-.87). Combined outcome was lower in the zinc group versus the placebo group (OR: .58; 95% CI .33-.99). Consistent results were observed in prespecified subgroups of patients aged <65 years, those with comorbidity, and those who needed oxygen therapy at baseline. Length of hospital stay was shorter in the zinc group versus the placebo group (difference: 3.5 days; 95% CI 2.76-4.23) in the inpatient group; duration of COVID-19 symptoms decreased with zinc treatment versus placebo in outpatients (difference: 1.9 days; 95% CI .62-2.6). No severe adverse events were observed during the study. CONCLUSIONS: Our results showed that, in COVID-19 patients, oral zinc can decrease 30-day death, ICU admission rate and can shorten symptom duration. Clinical Trials Registration. ClinicalTrials.gov, NCT05212480.

Pulse amplitude ratio under noninvasive ventilation as a new method in the diagnosis of left heart failure in patients with acute exacerbation of chronic obstructive pulmonary disease.

BACKGROUND: Left heart failure (LHF) is commonly associated with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) but its role is often underestimated. AIM OF STUDY: To evaluate the performance of a new diagnostic technique based on the measurement of the pulse amplitude ratio (PAR) using non-invasive ventilation (NIV) for the early identification LHF in patients admitted to the emergency department (ED) for AECOPD. RESULTS: 73 patients were included in this study: 32 in LHF group and 41 in non LHF- group. The two groups had comparable demographic and clinical characteristics at admission. The mean values of PARNIV was significantly higher among LHF patients (0.86 vs. 0.71; p < 0.01). The area under the receiver operating characteristic curve of PARNIV was 0.75. Using the best cut-off (0.6), the sensitivity of PARNIV was 93% with a specificity 21%, a positive predictive value of 48%, and a negative predictive value of 81%. Correlation between PARNIV and BNP was significant (r = 0.52; p = 0.002). CONCLUSION: Measurement of PARNIV in patients presenting to the ED with AECOPD had a good diagnostic performance for the detection of LHF and could represent an interesting alternative for the currently available methods. Trial registration The study was registered in the Clinical Trial Registration System (clinicaltrials.gov) under the study number NCT05189119, https://register. CLINICALTRIALS: gov/prs/app/action/SelectProtocol?sid=S000BOO4&selectaction=Edit&uid=U0000QAM&ts=2&cx=qrmluh .

Value of inferior vena cava collapsibility index as marker of heart failure in chronic obstructive pulmonary disease exacerbation.

INTRODUCTION: Inferior vena cava (IVC) diameter variability with respiration measured by ultrasound was found to be useful for the diagnosis of heart failure (HF) in ED patients with acute dyspnea. Its value in identifying HF in acute exacerbation of chronic obstructive pulmonary disease exacerbation (AECOPD) was not specifically demonstrated. OBJECTIVE: To determine the value of ΔIVC in the diagnosis of HF patients with AECOPD. METHODS: This is a prospective study conducted in the ED of three Tunisian university hospitals including patients with AECOPD. During this period, 401 patients met the inclusion criteria. The final diagnosis of HF is based on the opinion of two emergency experts after consulting the data from clinical examination, cardiac echocardiography, and BNP level. The ΔIVC was calculated by two experienced emergency physicians who were blinded from the patient's clinical and laboratory data. A cut off of 15% was used to define the presence (< 15%) or absence of HF (≥ 15%). Left ventricular ejection fraction (LVEF) was also measured. The area under the ROC curve, sensitivity, specificity, and positive and negative predictive values were calculated to determine the diagnostic and predictive accuracy of the ΔIVC in predicting HF. RESULTS: The study population included 401 patients with AECOPD, mean age 67.2 years with male (68.9%) predominance. HF was diagnosed in 165 (41.1%) patients (HF group) and in 236 patients (58.9%) HF was excluded (non HF group). The assessment of the performance of the ΔIVC in the diagnosis of HF showed a sensitivity of 37.4% and a specificity of 89.7% using the threshold of 15%. The positive predictive value was 70.9% and the negative predictive value was 66.7%. The area under the ROC curve was 0.71(95%, CI 0.65-0.76). ΔIVC values were not different between HF patients with reduced LVEF and those with preserved LVEF. CONCLUSION: Our results showed that ΔIVC has a good value for ruling out HF in ED patients consulting for AECOPD.

Analgesic Effect of Topical Piroxicam vs Phytotherapy Gel in the Treatment of Acute Soft Tissue Injuries: A Randomized Controlled Noninferiority Study.

OBJECTIVE: The study compared the efficacy and tolerability of piroxicam gel and a new topical combination of medicinal plant products (Soulagel®; Belpharma Tunisia) to treat pain caused by soft tissue injuries. METHODS: Patients (n = 1,525) were assigned to receive piroxicam gel or Soulagel. Efficacy assessments included a change of at least 50% in the pain-on-movement visual numeric scale rating from emergency department discharge (baseline) to day 7 final assessment, as well as the time required to reach pain resolution criteria, the need for rescue analgesia, patients' satisfaction, and the rate of adverse effects. RESULTS: At day 7, 1,216 patients (79.7%) achieved at least 50% reduction in visual numeric scale rating from baseline: 623 patients (82.4%) in the Soulagel group vs 593 patients (77.1%) in the piroxicam group (P = 0.01). Time to decrease pain on movement by 50% was significantly higher with piroxicam gel than with Soulagel (34 ± 1 vs 33 ± 1 days, respectively; P = 0.54). At day 7, 96.4% of patients in the Soulagel group declared being "very satisfied" to "satisfied," vs 68% in the piroxicam group (P < 0.001). There were no major adverse events in either group. CONCLUSIONS: Soulagel is not inferior to piroxicam gel for managing pain related to a soft tissue injuries. Further studies will help ascertain whether this new gel offers an alternative treatment option for this common emergency department condition.

Comparison of simulation and video-based training for acute asthma.

BACKGROUND: Emergency medicine is particularly well suited to simulation training. However, evidence for the efficacy of simulation-based medical training remains limited especially to manage high-risk cases such as acute asthma. OBJECTIVE: The objective of our study was to compare the performance of high-fidelity simulation (HFS) and interactive video-case challenge-based training (IVC) for final-year medical students in the management of acute asthma. METHODS: This was a prospective randomized controlled study conducted at the emergency department (ED) of Monastir University hospital ( Tunisia). 69 final-year medical students were randomized to HFS (n = 34) and IVC (n = 35) training on acute asthma topic. The study was conducted over a 1-week period. Efficacy of each teaching method was compared through the use of multiple-choice questionnaires (MCQ) before (pre-test), after (post-test) training and a simulation scenario test conducted 1 week later. The scenario was based on acute asthma management graded on predefined critical actions using two scores: the checklist clinical score (range 0 to 30), and the team skills score (range 0 to 16). Student satisfaction was also evaluated with the Likert 5 points scale. Two years after the post-test, both groups underwent a third MCQ testing to assess sustainability of knowledge. RESULTS: There were no differences in age between groups. There was no statistically significant difference between the HFS and IVC groups pre-test scores (p = 0.07). Both groups demonstrated improvement in MCQ post-test from baseline after training session; the HFS MCQ post-test score increased significantly more than the IVC score (p < 0.001). The HFS group performed better than the IVC group on the acute asthma simulation scenario (p < 0.001). Mean checklist clinical score and mean team skills score were significantly higher in HFS group compared to IVC group (respectively 22.9 ± 4.8 and 11.5 ± 2.5 in HFS group vs 19.1 ± 3 and 8.4 ± 3.1 in IVC group) (p < 0.001). After 2 years, MCQ post-test scores decreased in both groups but the decrease was lower in HFS group compared to the IVC group. CONCLUSION: High-fidelity simulation-based training was superior to interactive video-case challenge for teaching final year medical students,and led to more long-term knowledge retention in the management of simulated acute asthma patients. TRIAL REGISTRATION: The study was registered at www. CLINICALTRIALS: gov NCT02776358 on 18/05/2016.

30 day predicted outcome in undifferentiated chest pain: multicenter validation of the HEART score in Tunisian population.

BACKGROUND: Chest pain remains one of the most challenging serious complaints in the emergency department (ED). A prompt and accurate risk stratification tool for chest pain patients is paramount to help physcian effectively progrnosticate outcomes. HEART score is considered one of the best scores for chest pain risk stratification. However, most validation studies of HEART score were not performed in populations different from those included in the original one. OBJECTIVE: To validate HEART score as a prognostication tool, among Tunisian ED patients with undifferentiated chest pain. METHODS: Our prospective, multicenter study enrolled adult patients presenting with chest pain at chest pain units. Patients over 30 years of age with a primary complaint of chest pain were enrolled. HEART score was calculated for every patient. The primary outcome was major cardiovascular events (MACE) occurrence, including all-cause mortality, non-fatal myocardial infarction (MI), and coronary revascularisation over 30 days following the ED visit. The discriminative power of HEART score was evaluated by the area under the ROC curve. A calibration analysis of the HEART score in this population was performed using Hosmer-Lemeshow goodness of test. RESULTS: We enrolled 3880 patients (age 56.3; 59.5% males). The application of HEART score showed that most patients were in intermediate risk category (55.3%). Within 30 days of ED visit, MACE were reported in 628 (16.2%) patients, with an incidence of 1.2% in the low risk group, 10.8% in the intermediate risk group and 62.4% in the high risk group. The area under receiver operating characteristic curve was 0.87 (95% CI 0.85-0.88). HEART score was not well calibrated (χ2 statistic = 12.34; p = 0.03). CONCLUSION: HEART score showed a good discrimination performance in predicting MACE occurrence at 30 days for Tunisian patients with undifferentiated acute chest pain. Heart score was not well calibrated in our population.

Value of Dynamic Variation of Impedance Cardiac output in the diagnosis of Heart Failure in emergency department patients with undifferentiated dyspnea.

AIM OF STUDY: Cardiac output (CO) responses to acute changes in body position and Valsalva maneuver (VM) were proposed to assess cardiac contractile reserve. We investigated the value of sitting position (SP), leg raising (LR), and VM for identifying heart failure (HF) in patients with undifferentiated dyspnea. MATERIALS AND METHODS: It is a prospective study including patients over 18 years old admitted to the emergency department (ED) for dyspnea. Bioimpedance CO was measured at baseline, under SP, LR, and VM. HF diagnosis was based on clinical assessment, serum levels of brain natriuretic peptide (BNP) and echocardiography findings. Study population was divided into patients with heart failure (HF group) and patients without HF (HF- group). Diagnostic performance of CO change under the three maneuvers was calculated by sensitivity, specificity, likelihood ratio and receiver operating characteristic (ROC) curve. RESULTS: 290 patients were enrolled in the study. The final diagnosis was dyspnea due to congestive heart failure in 147 patients (50.7%). CO change with VM was the most accurate exam in identifying congestive heart failure as the cause of dyspnea with a sensitivity, specificity, positive and negative likelihood ratios of 79%, 60%, 1.97, and 0.36 respectively. Area under ROC curve was 0.62(95% CI, 0.55-0.69), 0.63(95% CI, 0.56-0.69), and 0.70(95% CI, 0.64-0.76) respectively for SP, LR, and VM. In a multivariate analysis, CO change with VM, but not with SP or LR, carried independent diagnostic value (p < 0.001). CONCLUSION: the diagnosis of HF can be aided with use of analyzing the effect of VM on non-invasively measured CO among patients admitted to the ED with undifferentiated dyspnea. Diagnostic yield of SP and LR was poor.

Value of systolic time intervals in the diagnosis of heart failure in emergency department patients with undifferentiated dyspnea.

AIM OF THE STUDY: The diagnosis of heart failure in the emergency department (ED) is challenging. The aim of this study was to evaluate systolic time intervals (STIs) using phonoelectrocardiography for the diagnosis of heart failure (HF) in ED patients with undifferentiated dyspnea. METHODS: A total of 855 patients with dyspnea and suspected HF were prospectively enrolled. They underwent echocardiographic measurements of left ventricular ejection fraction (LVEF), B-type natriuretic peptide (BNP) testing and computerised phonoelectrocardiography to assess STIs including electromechanical activation time (EMAT), left ventricular ejection time (LVET) and EMAT/LVET ratio. Diagnosis accuracy of STIs was calculated including sensitivity, specificity, likelihood ratio and receiver operating characteristic (ROC) curve. RESULTS: Patients with HF (n = 530) had significantly higher EMAT and lower LVET compared with non-HF patients. ROC curve c-statistic was 0.74, 0.72 and 0.78 for EMAT, LVET and EMAT/LVET respectively. Sensitivity and specificity of EMAT/LVET at a cut-off = 40% were 72% and 88% respectively. EMAT/LVET had the highest correlation with LVEF (r = 0.48). In patients with intermediate BNP (n = 107), positive likelihood ratio increased from 1.8 with BNP alone to 3.6 with BNP combined to EMAT/LVET. Patients without HF had STIs values not significantly different from those with preserved LVEF (≥45%). CONCLUSIONS: Given their immediate availability, phonoelectrocardiography STIs' parameters and particularly EMAT/LVET ratio could have an important role in the diagnosis approach of HF in patients with undifferentiated dyspnea in the ED.

Effect on Morphine Requirement of Early Administration of Oral Acetaminophen vs. Acetaminophen/Tramadol Combination in Acute Pain.

OBJECTIVES: To evaluate the effect on opioid requirement of pain treatment starting at triage, and to evaluate satisfaction in emergency department (ED) patients with acute pain. METHODS: This is a single-blind, randomized, prospective study conducted in the ED. The included patients were randomly assigned to single oral doses of placebo, acetaminophen, or a tramadol/acetaminophen combination. Protocol treatment was given at triage. The primary outcome was the need for rescue morphine during ED stay. The secondary outcome included patient satisfaction, ED length of stay, and percentage of patients discharged from the ED with a VAS score of <30. RESULTS: We included 1,485 patients: 496 patients in the placebo group, 497 in the acetaminophen group, and 492 in the tramadol/acetaminophen combination group. The groups were similar regarding demographic and clinical characteristics and baseline VAS pain scores. Rescue morphine was significantly decreased in the tramadol/acetaminophen combination group compared to that in the placebo and acetaminophen groups (11.5%, 23.2%, and 18.9%, respectively; P = 0.03). Patient satisfaction was higher in the tramadol/acetaminophen combination group (77% vs. 69% in the acetaminophen group and 68% in the placebo group). A VAS score of <30 was observed in 84% of patients in the placebo group, 83% in the acetaminophen group, and 87% in the tramadol/acetaminophen combination group (P = 0.01 between the acetaminophen group and tramadol/acetaminophen combination group). The ED length of stay was 60 minutes for the acetaminophen group and tramadol/acetaminophen combination group and 71 minutes for the placebo group (P = 0.04). CONCLUSION: Oral tramadol/acetaminophen combination administered early in triage was associated with a decrease in intravenous morphine requirement and increase in satisfaction among ED patients with acute pain when compared with patients taking acetaminophen. No significant increase in side effects was found. This intervention may be considered in EDs with an aim of similar benefits.

Management of acute coronary syndrome in emergency departments: a cross sectional multicenter study (Tunisia).

BACKGROUND: We aimed to describe diagnosed acute coronary syndrome (ACS) and its care management and outcomes in emergency departments (EDs) and to determine related cardiovascular risk factors (CVRFs). METHODS: We conducted a cross sectional multicenter study that included 1173 adults admitted to EDs for acute chest pain (ACP) in 2015 at 14 sites in Tunisia. Data included patients' baseline characteristics, diagnosis, treatment and output. RESULTS: ACS represented 49.7% of non-traumatic chest pain [95% CI: 46.7-52.6]; 74.2% of ACS cases were unstable angina/non-ST-segment-elevation myocardial infarction (UA/NSTEMI). Males represented 67.4% of patients with ACS (p < 0.001). The median age was 60 years (IQR 52-70). Emergency medical service transportation was used in 11.9% of cases. The median duration between chest pain onset and ED arrival was two hours (Inter quartile ranges (IQR) 2-4 h). The age-standardized prevalence rate was 69.9/100,000 PY; the rate was 96.24 in men and 43.7 in women. In the multivariable analysis, CVRFs related to ST segment elevation myocardial infarction were age correlated to sex and active smoking. CVRFs related to UA/NSTEMI were age correlated to sex, familial and personal vascular history and type 2 diabetes. We reported 27 cases of major adverse cardiovascular events (20.0%) in patients with STEMI and 36 in patients with UA/NSTEMI (9.1%). CONCLUSION: Half of the patients consulting EDs with ACP had ACS. Emergency medical service transportation calls were rare. Management delays were acceptable. The risk of developing an UA/NSTEMI was equal to the number of CVRFs + 1. To improve patient outcomes, it is necessary to increase adherence to international management guidelines.

Acupuncture vs intravenous morphine in the management of acute pain in the ED.

BACKGROUND: Acupuncture is one of the oldest techniques to treat pain and is commonly used for a large number of indications. However, there is no sufficient evidence to support its application in acute medical settings. METHODS: This was a prospective, randomized trial of acupuncture vs morphine to treat ED patients with acute onset moderate to severe pain. Primary outcome consists of the degree of pain relief with significant pain reduction defined as a pain score reduction ≥50% of its initial value. We also analyzed the pain reduction time and the occurrence of short-term adverse effects. We included in the protocol 300 patients with acute pain: 150 in each group. RESULTS: Success rate was significantly different between the 2 groups (92% in the acupuncture group vs 78% in the morphine group P<.001). Resolution time was 16±8 minutes in the acupuncture group vs 28±14 minutes in the morphine group (P<.005). Overall, 89 patients (29.6%) experienced minor adverse effects: 85 (56.6%) in morphine group and 4 (2.6%) in acupuncture group (P<.001). No major adverse effects were recorded during the study protocol. In patients with acute pain presenting to the ED, acupuncture was associated with more effective and faster analgesia with better tolerance. CONCLUSION: This article provides an update on one of the oldest pain relief techniques (acupuncture) that could find a central place in the management of acute care settings. This should be considered especially in today's increasingly complicated and polymedicated patients to avoid adverse drug reactions.

Willingness to participate in health research: Tunisian survey.

BACKGROUND: Few studies have identified the willingness rate of developing countries population to be enrolled in clinical trials. METHODS: All participants including patients (n = 612), healthy volunteers (n = 354) and doctors (n = 134) completed a questionnaire to examine factors affecting the consent to participate in medical research. RESULTS: Overall, 80 % of the included population agree to participate in health research. This rate was lower for trials dealing with life-threatening diseases (38 %). Altruism and perceived risk of harm were the main reason to respectively accept or refuse to participate in clinical trials. Factors significantly associated with willingness were: age <40 years (Odds Ratio (OR) 1.6 [95 % Confidence Interval (CI) 1.2-2.1]) and prior history of blood donation (OR 2.4 [95 % CI 1.7-3.5]). CONCLUSION: Most participants expressed their willingness to be included in medical research especially if they are young or if they have history of blood donation. However, consent to participate is low when medical research required acute care.

The risk of acute coronary syndrome in Ramadan.

BACKGROUND: Data on the effect of fasting on coronary disease are rare and controversial. The aim of our study was to investigate the influence of Ramadan on the prevalence of acute coronary syndrome among chest pain patients in the emergency department of Monastir. METHODS: It was a prospective study, performed in the emergency department of Fattouma Bourguiba University Hospital of Monastir, during the 3 months before, during and after Ramadan from 2012 to 2014. We included all patients with non-traumatic chest pain during the study period. Data were collected using a standardized form. The uniformity chi 2 test, ANOVA test, Kruskal-Wallis test were performed at the 5% level. Binary logistic regression model was used for multivariate analysis. RESULTS: The SCA prevalence was 17% a month before Ramadan, 22% during Ramadan and 28% one month after Ramadan (p = 0.007). According to the results of the multivariate analysis, the period of Ramadan is not associated with increase of risk of SCA whereas the risk doubles after Ramadan in all group (p = 0.001). In subgroups analysis, the period of R was associated with an amplification of risk in men aged more than 55 years and women older than 65 years (OR: 2.1; p = 0.020) and among subjects with hypertension (OR: 2.4, p = 0.007). Ramadan and Shawwal were not associated with an increase of risk among subjects without CVX risk factor. CONCLUSION: We have demonstrated that the risk of SCA has increased in Ramadan only among the elderly and patient with hypertension. The increased risk in Shawwal can be explained by the lifting of dietary restriction.

The risk of acute coronary syndrome in Ramadan.

BACKGROUND: Data on the effect of fasting on coronary disease are rare and controversial. The aim of our study was to investigate the influence of Ramadan on the prevalence of acute coronary syndrome among chest pain patients in the emergency department of Monastir. METHODS: It was a prospective study, performed in the emergency department of Fattouma Bourguiba University Hospital of Monastir, during the 3 months before, during and after Ramadan from 2012 to 2014. We included all patients with non-traumatic chest pain during the study period. Data were collected using a standardized form. The uniformity chi 2 test, ANOVA test, Kruskal-Wallis test were performed at the 5% level. Binary logistic regression model was used for multivariate analysis. RESULTS: The SCA prevalence was 17% a month before Ramadan, 22% during Ramadan and 28% one month after Ramadan (p = 0.007). According to the results of the multivariate analysis, the period of Ramadan is not associated with increase of risk of SCA whereas the risk doubles after Ramadan in all group (p = 0.001). In subgroups analysis, the period of R was associated with an amplification of risk in men aged more than 55 years and women older than 65 years (OR: 2.1; p = 0.020) and among subjects with hypertension (OR: 2.4, p = 0.007). Ramadan and Shawwal were not associated with an increase of risk among subjects without CVX risk factor. CONCLUSION: We have demonstrated that the risk of SCA has increased in Ramadan only among the elderly and patient with hypertension. The increased risk in Shawwal can be explained by the lifting of dietary restriction.

Efficacy and safety of nebulized morphine given at 2 different doses compared to IV titrated morphine in trauma pain.

BACKGROUND: Our aim was to compare the efficacy and safety of intravenous (IV) titrated morphine with nebulized morphine given at 2 different doses in severe traumatic pain. METHODS: In a prospective, randomized, controlled double-blind study, we included 300 patients with severe traumatic pain. They were assigned to 3 groups: Neb10 group received 1 nebulization of 10-mg morphine; Neb20 group received 1 nebulization of 20-mg morphine, repeated every 10 minutes with a maximum of 3 nebulizations; and the IV morphine group received 2-mg IV morphine repeated every 5 minutes until pain relief. Visual analog scale was monitored at baseline, 5, 10, 15, 20, 25, 30, and 60 minutes after the start of drug administration. Treatment success was defined by the percentage of patients in whom visual analog scale decreased greater than or equal to 50% of its baseline value. When this end point was not reached, rescue morphine was administered. Pain resolution time was defined by the elapsed time between the start of the protocol and the reach of treatment success criteria. RESULTS: Success rate was significantly better at 97% (95% confidence interval [CI], 93-100) for Neb20 group compared to Neb10 group (81% [95% CI, 73-89]) and IV morphine group (79% [95% CI, 67-84]). The lowest resolution time was observed in Neb20 group (20 minutes [95% CI, 18-21]). Side effects were minor and significantly lower in both nebulization groups compared to IV morphine group. CONCLUSIONS: Nebulized morphine using boluses of 10 mg has similar efficacy and better safety than IV titrated morphine in patients with severe posttraumatic pain. Increasing nebulized boluses to 20 mg increases the effectiveness without increasing side effects.

Piroxicam and paracetamol in the prevention of early recurrent pain and emergency department readmission after renal colic: Randomized placebo-controlled trial.

OBJECTIVE: Renal colic (RC) is a common urologic emergency often leading to significant pain and recurrent hospital visits. This study aimed to compare the efficacy and safety of piroxicam versus paracetamol in preventing pain recurrence and hospital readmission in patients treated for RC and discharged from the emergency department (ED). METHODS: A prospective, randomized, single-blind trial was conducted in four EDs. Eligible adults with RC were randomized to receive oral piroxicam, paracetamol, or placebo for 5 days post-ED discharge. Primary outcomes included pain recurrence and ED readmission within 7 days. Secondary outcomes included time to recurrence and treatment-related side effects. RESULTS: Of 1383 enrolled patients, no significant differences were observed among the groups regarding baseline characteristics. Pain recurrence rates within 7 days were 29% (95% confidence interval [CI] 24.9%-33.2%) for piroxicam, 30.3% (95% CI 26.1%-34.5%) for paracetamol, and 30.8% (95% CI 26.6%-35.0%) for placebo, with no significant between-group differences (p = 0.84). Among patients experiencing recurrence, the majority encounter it within the initial 2 days following their discharge (86% in the piroxicam group, 84.1% in the paracetamol group, and 86% in the placebo group, respectively). ED readmission rates were similar across groups: 20.8% (95% CI 17.1%-24.5%) in the piroxicam group, 23.8% (95% CI 19.9%-27.7%) in the paracetamol group, and 22.9% (95% CI 19.1%-26.8%) in the placebo group (p = 0.52). The piroxicam group reported significantly higher adverse effects compared to others. CONCLUSIONS: Piroxicam and paracetamol did not demonstrate efficacy in preventing pain recurrence or ED readmission within the first week following RC treatment.

Prediction value of the Canadian CT head rule and the New Orleans criteria for positive head CT scan and acute neurosurgical procedures in minor head trauma: a multicenter external validation study.

STUDY OBJECTIVE: The New Orleans Criteria and the Canadian CT Head Rule have been developed to decrease the number of normal computed tomography (CT) results in mild head injury. We compare the performance of both decision rules for identifying patients with intracranial traumatic lesions and those who require an urgent neurosurgical intervention after mild head injury. METHODS: This was an observational cohort study performed between 2008 and 2011 on patients with mild head injury who were aged 10 years or older. We collected prospectively clinical head CT scan findings and outcome. Primary outcome was need for neurosurgical intervention, defined as either death or craniotomy, or the need of intubation within 15 days of the traumatic event. Secondary outcome was the presence of traumatic lesions on head CT scan. New Orleans Criteria and Canadian CT Head Rule decision rules were compared by using sensitivity specifications and positive and negative predictive value. RESULTS: We enrolled 1,582 patients. Neurosurgical intervention was performed in 34 patients (2.1%) and positive CT findings were demonstrated in 218 patients (13.8%). Sensitivity and specificity for need for neurosurgical intervention were 100% (95% confidence interval [CI] 90% to 100%) and 60% (95% CI 44% to 76%) for the Canadian CT Head Rule and 82% (95% CI 69% to 95%) and 26% (95% CI 24% to 28%) for the New Orleans Criteria. Negative predictive values for the above-mentioned clinical decision rules were 100% and 99% and positive values were 5% and 2%, respectively, for the Canadian CT Head Rule and New Orleans Criteria. Sensitivity and specificity for clinical significant head CT findings were 95% (95% CI 92% to 98%) and 65% (95% CI 62% to 68%) for the Canadian CT Head Rule and 86% (95% CI 81% to 91%) and 28% (95% CI 26% to 30%) for the New Orleans Criteria. A similar trend of results was found in the subgroup of patients with a Glasgow Coma Scale score of 15. CONCLUSION: For patients with mild head injury, the Canadian CT Head Rule had higher sensitivity than the New Orleans Criteria, with higher negative predictive value. The question of whether the use of the Canadian CT Head Rule would have a greater influence on head CT scan reduction requires confirmation in real clinical practice.

Mobile Phone-Based Telemonitoring for Improving Adherence to Analgesic Treatment in Trauma Patients After Emergency Department Discharge: A Randomized Controlled Trial.

OBJECTIVE: To determine the impact of mobile-phone telemonitoring on patients' adherence and satisfaction with posttrauma pain treatment. MATERIALS AND METHODS: We conducted a prospective randomized clinical trial including patients with minor trauma discharged from the emergency department (ED) with analgesic treatment. Patients were randomized to one of 3 groups, the control group, where patients received a phone call on day-7, the short message service (SMS) group, where patients received a daily text message to remind them to take their treatment during 7 days, and the mobile-phone based telemonitoring (TLM) group. Patients' adherence to analgesic treatments using the Morisky Medication Adherence Scale, current pain by using a visual analogue scale, and patients' satisfaction were assessed. For the TLM group, the assessment was performed at day-2, 4 and 7. RESULTS: Good adherence was observed in 418 patients (92.9%) in the TLM group versus 398 patients (88.6%) in the SMS group and 380 patients (84.8%) in the control group ( P <0.001). The factor mostly associated with adherence was telemonitoring (OR 2.40 95% CI 1.55-3.71). The decrease in pain visual analogue scale was highest in the TLM group compared with SMS and control groups ( P <0.001). The percentage of patients' satisfaction at 7 days post-ED discharge was 93% in the TLM group versus 88% in the SMS group and 84% in the standard group ( P =0.02). DISCUSSION: Our findings suggest that mobile-phone-based telemonitoring is beneficial in the treatment of pain in trauma patients after ED discharge. This approach improved patients' adherence and satisfaction.