Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-19
SponsorIWK Health Centre
About this trial
This research trial will measure how useful Aprepitant is in preventing nausea and vomiting in children having surgery to correct scoliosis (curvature of the spine).
Eligibility criteria
Qualifiers
Posterior Spinal Instrumentation and Fusion (PSIF) for idiopathic scoliosis
The fusion must include at least 6 vertebral levels.
Children greater than or equal to 8 years old, and less than 19 years old on the day of surgery
Weight > 40kg - for ease of pharmacy preparation (PONV dose 1mg per kg to max 40mg)
Disqualifiers
Patient/ Parent refusal
Hypersensitivity to Aprepitant or any ingredient in the formulation or oral solution. (previous allergy or adverse reaction to Aprepitant)
Developmental delay as reported by parents
Pregnant - Pregnancy test done as standard of care pre-operative
Trial design
Treatments tested in this trial
- Aprepitant
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov