Pharmacokinetics of intravenous ondansetron in healthy children undergoing ear, nose, and throat surgery.

BACKGROUND

To determine the pharmacokinetics of the 5-HT3 antagonist ondansetron in children, informed written consent was obtained from the parents of 21 healthy children aged from 3 to 12 years scheduled for ear, nose, and throat surgery.

METHODS

The children were stratified according to age: 3 to 7 years and 7.1 to 12 years, and a single intravenous infusion of 2 or 4 mg ondansetron, respectively, was administered over 5 minutes before induction of anesthesia. After completion of the infusion, anesthesia was induced intravenously and maintained with inhalational anesthesia. Whole blood (3 ml) was obtained before administration of ondansetron, at completion of the infusion, at the beginning and end of surgery, and at 3, 4, 6, 8, 10, and 12 hours after start of the infusion. Pharmacokinetic variables were determined with use of standard noncompartmental techniques.

RESULTS

Mean plasma clearance was 0.50 L.hr-1.kg-1 and 0.39 L.hr-1.kg-1, the mean volume of distribution at steady-state was 1.70 L.kg-1 and 1.61 L.kg-1, and the mean plasma terminal half-life was 2.6 hours and 3.1 hours for the 2 mg and 4 mg groups, respectively. On a body surface area basis, mean plasma clearance was 14.0 and 13.7 L.hr-1.m-2 and mean volume of distribution was 47.7 and 55.9 L.m-2 for the 2 and 4 mg groups, respectively. There were no serious adverse events attributable to ondansetron.

CONCLUSIONS

These data indicate that the pharmacokinetics of ondansetron in children from 3 to 12 years old are predictable and similar to those in adults. The elimination half-life of ondansetron increases in parallel with age. However, clearance is constant when normalized to body surface area, but the volume of distribution increases over the age range studied.