A randomized, placebo-controlled trial of a single dose of tropisetron for the prevention of vomiting after strabismus surgery in children.

摘要

PURPOSE: This study evaluates the effect of different doses of tropisetron to prevent postoperative vomiting, which frequently occurs in children following strabismus surgery. METHODS: One hundred twenty-five American Society of Anesthesiologists' classification (ASA) I-II group patients 2-12 years of age were randomized to this prospective, single-blind, placebo-controlled clinical study. Patients were placed in groups of 5 and did not receive any premedication. The first group received placebo, and the 2nd, 3rd, 4th, and 5th groups received 0.5 mg/m(2), 1 mg/m(2), 1.5 mg/m(2), and 2 mg/m(2) of tropisetron, respectively, following anesthesia induction. The same anesthetic technique and analgesia were used for all groups. The patients were examined for the presence of vomiting and for any complaints and side effects at 2, 6, and 24 hours after surgery. RESULTS: The incidence of postoperative vomiting (POV) was statistically more significant in the placebo group at 2, 6 and 24 hours, when compared to the study groups (p< 0.001), but there was no significant difference among tropisetron groups at 6-24 hours (p>0.05). There was no significant difference in terms of the incidence of POV among the study groups (16%, 16%, 24%, 20% respectively) at all periods (p>0.05). The number of patients with POV score of 3 was 10 in the placebo group, while it was 1, 2, 0 and 1 in the 2nd, 3rd, 4th, and 5th groups, respectively (p<0.01). CONCLUSIONS: Tropisetron (0.5, 1.0, 1.5 and 2.0 mg/m(2)) decreased the incidence and severity of POV following strabismus surgery in children. All of the doses seemed to be equally effective. There was no difference in POV control between placebo and any of the doses of the tropisetron after six hours. So we suggest that 0.5 mg/m(2) single-dose tropisetron is enough for preventing POV following strabismus surgery in children.