Effect of Intramuscular Ketamine versus Haloperidol on Short-Term Control of Severe Agitated Patients in Emergency Department; A Randomized Clinical Trial.

Abstract

Objective:To evaluate the efficacy and safety of intramuscular ketamine and haloperidol in sedation of severely agitated patients in emergency department (ED). Methods: This randomized, double-blind clinical trial study was performed on agitated patients referring to two university educational hospitals. Patients were randomly assigned to receive intramuscular (IM) haloperidol (5 mg) or IM ketamine (4 mg/kg). The primary outcome was time to adequate sedation (AMSS ≤ +1). Secondary outcomes included the need for additional sedatives, required intubation, duration of hospitalization, and side effects. Results:The 90 agitated patients were enrolled. The mean age was 30.37±7.36 years (range 18–56); 74% (67/90) were men. The mean time to adequate sedation in ketamine group (7.73 ± 4.71 minutes) was significantly lower than haloperidol group (11.42 ± 7.20 minutes) (p= 0.005). 15 minutes after intervention, the sedation score did not differ significantly in both groups (Ketamine:0.14 ± 0.59 vs. Haloperidol: 0.30 ± 0.60; p=0.167). The incidence of complications was not significantly different between groups. The physician's satisfaction from the patients’ aggression control was significantly higher in ketamine group. Conclusion:These data suggest ketamine may be used for short-term control of agitated patients, additional studies are needed to confirm if ketamine is safe in this patient population. Given rapid effective sedation and the higher physician satisfaction of ketamine in comparison to haloperidol, it may be considered as a safe and appropriate alternative to haloperidol.IRCT Code: IRCT20180129038549N5