Background: Postoperative vomiting (POV) after pediatric strabismus surgery remains a major problem. Objective:To evaluate the efficacy and safety of a single dose of ramosetron, a new serotonin antagonist, for preventing POV in children undergoing strabismus surgery. Method: In a prospective, randomized, double-masked, placebo-controlled study, 80 children (38 boys and 42 girls), aged 4 to 10 years, scheduled for strabismus surgery, received intravenously either placebo or ramosetr-on at 1 of 3 different doses (3 μ g/kg, 6 μ g/kg, or 12 μ g/kg) (n=20 each) at the end of the surgical procedure. A standard general anesthetic technique was used. Main Outcome Measures: Emetic episodes were recorded and safety assessments performed during the first and second 24- hour periods (ie, 0- 24 and 24- 48 hours) after receiving anesthesia. Results: The rate of patients who were emesis-free (defined as no retching and no vomiting), during the 0- to 24- hour period after anesthesia was 35% with3 μ g/kg of ramosetron (P=.37), 90% with 6 μ g/kg of ramosetron (P=.001), and 90% with 12 μ g/kg of ramosetron (P=.001) compared with placebo (25% ). The corresponding rate during the 24- to 48- hour period after anesthesia was 40% (P=.371), 90% (P=.001), and 90% (P=.001), respectively, compared with placebo (30% ). No clinically important adverse events were observed in any group. Conclusions: A 6- μ g/kg dose of ramosetron is sufficient, but a 3- μ g/kg dose is insufficient for preventing POV during the 0- to 48- hour period after anesthesia in children undergoing strabismus surgery. Increasing the dose to 12 μ g/kg of ramosetron provides no demonstrable additional benefit.
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