The Effect of Adjunctive Midazolam on Fentanyl Analgesia and Anxiolysis in Acute Limb Trauma: A Randomized Controlled Trial
Authors
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Mozhgan Sabzevari
Department of Emergency Medicine, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0009-0008-2341-0762
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Sepideh Mahdavi
Department of Epidemiology, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.
https://orcid.org/0000-0003-2161-5496
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Maryam Farjamfar
Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0002-0314-0311
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Amir Noyani
Department of Emergency Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0002-7951-9483
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Mohammad Reza Khorsand
Department of Emergency Medicine, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0002-6821-3286
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Mostafa Enayatrad
Clinical Research Development Unit, Bahar Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0003-3465-3715
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Maryam Abbaszadeh
Department of Emergency Medicine, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0003-0450-855X
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Seyed Meysam Yekesadat
Clinical Research Development Unit, Imam Hossein Hospital, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0002-1447-371X
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Hossein Amiri Largani
Department of Emergency Medicine, School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.
https://orcid.org/0000-0002-3303-873X
DOI:
https://doi.org/10.22100/ijhs.v12i3.1294Keywords:
Trauma, Pain, Anxiety, Midazolam, FentanylAbstract
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.
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