RESUMO
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.
RESUMO
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.