STUDY OBJECTIVE: To determine whether oral olanzapine or oral diazepam was more effective at achieving behavioral containment for young people presenting to the emergency department with acute severe behavioral disturbance.
METHODS: We conducted an open-label, multicenter, randomized controlled trial from October 22, 2021, to November 6, 2023. We enrolled young people aged between 9 and 17 years with acute severe behavioral disturbance deemed to require oral medication across 9 Australian emergency departments. We randomly assigned participants to a single weight-based oral dose of olanzapine or diazepam. The primary outcome was successful sedation (Sedation Assessment Tool score less than or equal to 0) without the need for additional sedatives one hour postrandomization. Secondary outcomes included adverse events; length of stay; aggression toward staff, participants, or parent/guardians; disposition; and satisfaction with care.
RESULTS: We recruited 348 participants, with 176 assigned to olanzapine and 172 to diazepam. Successful sedation without the requirement for additional sedatives occurred in 103/168 (61%) in the olanzapine group and 90/158 (57%) in the diazepam group (adjusted risk difference 3.6%, 95% confidence interval -6.7% to 14.0%). No serious adverse events were reported in either group.
CONCLUSIONS: There was no evidence that oral olanzapine resulted in a greater proportion of participants with acute severe behavioral disturbance achieving successful sedation at one hour postrandomization than oral diazepam. Neither medication resulted in any serious adverse events; however, approximately 40% of participants in each group did not achieve successful sedation.
| Discipline Area | Score |
|---|---|
| Pediatric Emergency Medicine |  |
| Emergency Medicine | |
| Psychiatry |  |
In this study of oral olanzapine vs oral diazepam in young adults and kids, there was a difference in sedation effect, but the inability to blind between groups potentially introduces significant biases. Also, more than half of patients who could have enrolled were not, which could have significantly affected the results (had they been enrolled). Lastly, the 9 sites over 2 years means that approximately 1 patient/month were enrolled, meaning the number of applicable patients that could qualify would be very small. With that being said, one possible take away is that oral olanzapine may be preferred because they are easier to administer in the ED because benzos are controlled substances (especially if controlled substances require additional security to access). Regardless, at least in pediatrics, oral diazepam and oral olanzapine performed the same.
Disappointing that the medications were successful in only approximately 60% of patients. Useful to know that olanzapine and diazepam are equivalent in treating children with acute agitation in the ED.
Well conducted trial of an increasing and important patient group: agitated patients in pediatric EDs. The findings match that clinical feeling that there is no single effective treatment. Instead, a great proportion of patients remained agitated.
This is useful information especially for smaller EDs.
