RETRACTED: A randomized clinical trial of a single dose of ramosetron for the prevention of vomiting after strabismus surgery in children - A dose-ranging study (Retracted article. See vol. 130, pg. 952, 2012)

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 ramosetron at I of 3 different doses (3 mug/kg, 6 mug/kg, or 12 mug/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% with 3 mug/kg of ramosetron (P=.37), 90% with 6 mug/kg of ramosetron (P=.001), and 90% with 12 mug/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-mug/kg dose of ramosetron is sufficient, but a 3-mug/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 mug/kg of ramosetron provides no demonstrable additional benefit.