We performed a double-blind, randomized, placebo-controlled trial to i
nvestigate the efficacy and safety of ondansetron in preventing vomiti
ng after tonsillectomy with or without adenoidectomy in children. Sixt
y children were premedicated with 0.5 mg/kg of oral midazolam and unde
rwent inhaled induction and maintenance of anesthesia with halothane a
nd nitrous oxide. intravenous morphine 0.075 mg/kg, vecuronium 0.1 mg/
kg, and either ondansetron 0.15 mg/kg (maximum = 8 mg), or saline plac
ebo were administered after intravenous catheter placement. All episod
es of postoperative vomiting on the day of surgery and the following d
ay were recorded. There were no significant differences between the tw
o groups with regard to age, weight, sex, time to endotracheal intubat
ion, duration of surgery, duration of anesthesia, or number of patient
s having adenoidectomy. More patients in the ondansetron group receive
d dexamethasone as part of the surgeon's routine protocol (P = 0.03).
Twenty-three children (77%) who received ondansetron were emesis-free
as opposed to only eight (27%) in the placebo group (P < 0.001). This
was especially evident in the number of children who had two or more e
pisodes of vomiting; 17 children (57%) who received placebo had two or
more episodes of vomiting as opposed to only two children (7%) who re
ceived ondansetron. The incidence of emesis on the day after the surge
ry did not differ between the two groups. Three children who received
ondansetron and one who received placebo complained of abdominal cramp
ing on the night of the surgery. There were no other complaints or com
plications. Analysis of the 51 children who did not receive dexamethas
one revealed similar results. Likewise, there were no significant diff
erences between children who received ondansetron plus dexamethasone a
nd those who received ondansetron alone. It thus seems that intravenou
s ondansetron, 0.15 mg/ kg, when given shortly after induction of anes
thesia, safely and effectively decreases the incidence and severity of
vomiting in children after tonsillectomy with or without adenoidectom
y.