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Background: The reduction of shoulder dislocation requires adequate procedural sedation and analgesia. The mixture of midazolam and fentanyl is reported in the literature, but long-acting benzodiazepines in conjunction with fentanyl are lacking., Study Objective: Our aim was to compar e IV diazepam with IV midazolam in moderate procedural sedation (based on the classification of the American Society of Anesthesiologists) for the reduction of shoulder dislocation., Methods: This was a randomized controlled clinical trial conducted from April 2019 to December 2019 in the emergency department of a university-affiliated hospital in Tehran, Iran. Participants were adult patients (aged 18-65 years) with anterior shoulder dislocation. Group A (n = 42) received diazepam 0.1 mg/kg plus fentanyl 1 μg/kg IV and group B received midazolam 0.1 mg/kg plus fentanyl 1 μg g/kg IV. Main outcomes measured were onset of muscle relaxation, time taken to reduction, total procedure time, number of the reduction attempts, patient recovery time, the occurrence of the adverse effects, amount of the pain reported by the patients using visual analog scale, and patients and physicians overall satisfaction with the procedure using a Likert scale question., Results: Eighty-one patients were included. The mean ± standard deviation time of the onset of the muscle relaxation and time taken to reduction was shorter in the diazepam plus fentanyl group (p = 0.016 and p = 0.001, respectively). Adverse effects and pain relief were not statistically different between the two groups. Patient recovery time and total procedure time was shorter in the midazolam plus fentanyl group (p = 0.008 and p = 0.02, respectively). The overall satisfaction of patients and physicians was higher in the diazepam plus fentanyl group., Conclusions: As compared with midazolam plus fentanyl, diazepam plus fentanyl was superior in terms of the onset of the muscle relaxation, patient and physician satisfaction, and time taken to reduction., (Copyright © 2020 Elsevier Inc. All rights reserved.)