The Effect of Adjunctive Midazolam on Fentanyl Analgesia and Anxiolysis in Acute Limb Trauma: A Randomized Controlled Trial

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 ۲۰۲۱, ۷۸ adults (۱۸–۸۰ years) with direct limb trauma (GCS=۱۵, SBP>۹۰ mmHg) were randomly assigned to receive IV fentanyl (۱ µg/kg) plus either ۱ mL saline or midazolam (۱ mg if <۵۰ kg, ۲ mg if ۵۰–۷۵ kg, ۳ mg if >۷۵ kg). Pain was assessed by Visual Analog Scale (VAS) at baseline, ۳۰ min, and ۶۰ min; anxiety by Depression Anxiety Stress Scales (DASS) before and ۶۰ min post injection. Vital signs and adverse events were monitored; a rescue dose was given if VAS did not decrease by ≥۲ points at ۳۰ min. Repeated measures ANOVA, paired and unpaired t-tests, and chi-square tests were applied with α=۰.۰۵.Results: Both groups had significant reductions in pain over time (P-value=۰.۰۰۱) and anxiety (P-value=۰.۰۰۱). Between-group differences were nonsignificant for pain at ۳۰ min (P-value=۰.۶۹۷) and ۶۰ min (P-value=۰.۱۲۴) and for anxiety (P-value=۰.۸۰۲). 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.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 ۲۰۲۱, ۷۸ adults (۱۸–۸۰ years) with direct limb trauma (GCS=۱۵, SBP>۹۰ mmHg) were randomly assigned to receive IV fentanyl (۱ µg/kg) plus either ۱ mL saline or midazolam (۱ mg if <۵۰ kg, ۲ mg if ۵۰–۷۵ kg, ۳ mg if >۷۵ kg). Pain was assessed by Visual Analog Scale (VAS) at baseline, ۳۰ min, and ۶۰ min; anxiety by Depression Anxiety Stress Scales (DASS) before and ۶۰ min post injection. Vital signs and adverse events were monitored; a rescue dose was given if VAS did not decrease by ≥۲ points at ۳۰ min. Repeated measures ANOVA, paired and unpaired t-tests, and chi-square tests were applied with α=۰.۰۵. Results: Both groups had significant reductions in pain over time (P-value=۰.۰۰۱) and anxiety (P-value=۰.۰۰۱). Between-group differences were nonsignificant for pain at ۳۰ min (P-value=۰.۶۹۷) and ۶۰ min (P-value=۰.۱۲۴) and for anxiety (P-value=۰.۸۰۲). 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.

کلیدواژه ها:

Trauma ، Pain ، Anxiety ، Midazolam ، Fentanyl