Shahroud University of Medical siences Shahroud Journal of Medical Sciences 2423-6594 12 3 2026 06 03 The Effect of Adjunctive Midazolam on Fentanyl Analgesia and Anxiolysis in Acute Limb Trauma: A Randomized Controlled Trial 9 12 eng Mozhgan Sabzevari Department of Emergency Medicine, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.. dr.sabzevari7@gmail.com Sepideh Mahdavi Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.. s.mahdavi88@gmail.com Maryam Farjamfar Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.. m.farjamfar@yahoo.com Amir Noyani Department of Emergency Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.. noyaniamir@gmail.com Mohammad Reza Khorsand Department of Emergency Medicine, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.. dr_Khorsandmd@yahoo.com Mostafa Enayatrad Clinical Research Development Unit, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.. mostafaenayatrad@gmail.com Maryam Abbaszadeh Department of Emergency Medicine, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.. maryamabbaszadehmsp@gmail.com Seyed Meysam Yekesadat Clinical Research Development Unit, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.. dr.semeye@gmail.com Hossein Amiri Largani Department of Emergency Medicine, School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.. amirilargani@gmail.com 2025 07 01 2025 11 15 Background: We compared combined midazolam–fentanyl versus fentanyl alone for anxiety and pain relief in adult limb trauma patients. Methods: In this double-blind randomized trial at Imam Hossein Hospital (Shahroud, Iran) during 2021, 78 adults (18–80 years) with direct limb trauma (GCS=15, SBP>90 mmHg) were randomly assigned to receive IV fentanyl (1 µg/kg) plus either 1 mL saline or midazolam (1 mg if <50 kg, 2 mg if 50–75 kg, 3 mg if >75 kg). Pain was assessed by Visual Analog Scale (VAS) at baseline, 30 min, and 60 min; anxiety by Depression Anxiety Stress Scales (DASS) before and 60 min post injection. Vital signs and adverse events were monitored; a rescue dose was given if VAS did not decrease by ≥2 points at 30 min. Repeated measures ANOVA, paired and unpaired t-tests, and chi-square tests were applied with α=0.05. Results: Both groups had significant reductions in pain over time (P-value=0.001) and anxiety (P-value=0.001). Between-group differences were nonsignificant for pain at 30 min (P-value=0.697) and 60 min (P-value=0.124) and for anxiety (P-value=0.802). No episodes of hypotension or respiratory depression occurred. Conclusion: Co-administration of midazolam augments fentanyl’s anxiolytic effect and provides equivalent analgesia without additional cardiorespiratory compromise.