Thiopental-Fentanyl versus Midazolam-Fentanyl for Emergency Department Procedural Sedation and Analgesia in Patients with Shoulder Dislocation and Distal Radial Fracture-Dislocation: A Randomized Double-Blind Controlled Trial

Background and aim: It has not been well studied
whether fentanyl-thiopental (FT) is effective and safe for PSA in
orthopedic procedures in Emergency Department (ED). The aim of
this trial was to evaluate the effectiveness of intravenous FT versus
fentanyl-midazolam (FM) in patients who suffered from shoulder
dislocation or distal radial fracture-dislocation.
Methods: In this randomized double-blinded study, Seventy-six
eligible patients were entered the study and randomly received
intravenous FT or FM. The success rate, onset of action and recovery
time, pain score, physicians’ satisfaction and adverse events were
assessed and recorded by treating emergency physicians. The
statistical analysis was intention to treat.
Results: The success rate after administrating loading dose in FT
group was significantly higher than FM group (71.7% vs. 48.9%,
p=0.04); however, the ultimate unsuccessful rate after 3 doses of
drugs in the FT group was higher than the FM group (3 to 1) but it
did not reach to significant level (p=0.61). Despite near equal onset
of action time in two study group (P=0.464), the recovery period in
patients receiving FT was markedly shorter than FM group
(P<0.001). The occurrence of adverse effects was low in both groups
(p=0.31).
Conclusion: PSA using FT is effective and appears to be safe for
orthopedic procedures in the ED. Therefore, regarding the prompt
onset of action, short recovery period of thiopental, it seems that this
combination can be considered more for performing PSA in
orthopedic procedures in ED.





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