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Clinical Trials |

A Randomized Clinical Trial of a Single Dose of Ramosetron for the Prevention of Vomiting After Strabismus Surgery in Children:  A Dose-Ranging Study

Yoshitaka Fujii, MD; Hiroyoshi Tanaka, MD; Mutsuko Ito, MD
Arch Ophthalmol. 2005;123(1):25-28. doi:10.1001/archopht.123.1.25.
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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 1 of 3 different doses (3 μg/kg, 6 μg/kg, or 12 μg/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 μg/kg of ramosetron (P = .37), 90% with 6 μg/kg of ramosetron (P = .001), and 90% with 12 μg/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-μg/kg dose of ramosetron is sufficient, but a 3-μg/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 μg/kg of ramosetron provides no demonstrable additional benefit.

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