LAUSR

10527Background: Fosaprepitant, is a Neurokinin-1 (NK-1) receptor antagonist, approved in adults for the prevention of vomiting associated with administration of moderately or highly emetogenic chemotherapeutic agents. The efficacy and safety of fosaprepitant in children is not known. Therefore, we conducted a phase III randomized trial to assess the safety and efficacy of fosaprepitant in children. Methods: The study was a phase III, single centre, double blind, randomized placebo controlled trial. Children aged 1-12 years with documented malignancy, who were scheduled to receive moderately or highly emetogenic chemotherapy, were randomly assigned to arm A (Fosaprepitant) or arm B (Placebo). Arm A received intravenous ondansetron (0.15 mg/kg) plus dexamethasone (0.075 mg/kg) followed by fosaprepitant (3 mg/kg) short infusion. Arm B received intravenous ondansetron (0.15 mg/kg) plus dexamethasone (0.15 mg/kg) followed by normal saline as placebo. Oral ondansetron and dexamethasone were continued for 48 ho...