Agitation and/or aggression after traumatic brain injury in the pediatric population treated with ziprasidone. Clinical article

Abstract

Object: Agitation and aggression are common after traumatic brain injury (TBI) and can hamper recovery and rehabilitative efforts. To date, there is no consensus on pharmaceutical intervention for these conditions after TBI. Ziprasidone has been reported efficacious in this population but the evidence is limited. The authors report their experience of using ziprasidone to treat posttraumatic brain injury agitation in 20 consecutive pediatric patients. A secondary objective of this case series was to attempt to establish an age-specific dosage and identify possible side effects of this medication.

Methods: This case series study was performed at a university hospital and pediatric trauma center. Over an 18-month period, all patients who presented to the pediatric intensive care unit with TBI and later developed agitation and/or aggression were treated with ziprasidone as the sole intervention. Pre- and posttreatment scores on the Riker Sedation-Agitation Scale (SAS) were recorded along with demographic data.

Results: Twenty children received ziprasidone for agitation and/or aggression during the immediate recovery period from TBI. The median patient age was 8 years (range 9 months-17 years). Children were stratified into 4 age groups: <2 years old (Group 1), 2-6 years old (Group 2), 7-12 years old (Group 3), and >or=13 years old (Group 4). The SAS score, before and 24 hours after the initiation of ziprasidone, demonstrated a significant reduction after initiation of the medication (p<0.001). The initial dose for Groups 1-4 was 1.7, 0.9, 0.7, and 0.6 mg/kg, respectively, with final doses of 1.8, 1.5, 1.7, and 0.07 mg/kg, respectively. The duration of therapy for Groups 1-4 was 5, 8, 6, and 3 days, respectively. All patients received continuous cardiac and blood-pressure monitoring. No adverse events were reported in any of the age groups.

Conclusions: Based on this limited patient series, ziprasidone appears to be safe and effective in pediatric patients with closed head injuries who develop agitation and/or aggression in the immediate postinjury period. Ziprasidone consistently lowered SAS scores and did so in all age groups. There were minimal dose adjustments and the duration of therapy was relatively brief. No adverse events were reported. A prospective trial of ziprasidone in this population appears warranted.