Conditions: Postoperative Nausea and Vomiting
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 98
Healthy volunteers: no

Brief summary:
This two part study will determine the appropriate dosing regimen of aprepitant for the prevention of postoperative nausea and vomiting (PONV) in pediatric participants 6 months to 17 years of age, by assessing pharmacokinetic parameters and monitoring safety and tolerability of administered doses. Part I will be an open label investigation of a single dose of aprepitant measuring pharmacokinetics at specified time points up to 48 hours after aprepitant dosing. Part II will be a double blind trial of participants randomized to receive either aprepitant or ondansetron.

Detailed description:

Arms:
arm 1: In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. arm 2: In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant on Day 1. arm 3: In Study Part 2, participants aged 6 months to 17 years received a single intravenous dose of ondansetron on Day 1.

Interventions: intervention 1: Aprepitant intervention 2: Ondansetron
Intervention descriptions: intervention 1: Aprepitant administered orally or intraveously. intervention 2: Ondansetron administered intravenously.

Protocol document: