Overview
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).
Description
Detailed Description: This prospective, randomized, controlled trial will test whether adding Aprepitant to standard multimodal therapy regimen can further reduce the incidence and severity of post-operative nausea and vomiting (PONV) in children undergoing posterior spinal instrumentation and fusion. The primary outcome of the study will be anti-nausea rescue medication administration post-surgery, with secondary outcomes being the first instance of post-surgery anti-nausea rescue medication administration, emesis, headache, flatus, bowel movement, and sensation of itch; incidence of treatment-emergent adverse events; and worst nausea and pain scores post-surgery .
Eligibility
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- Severe systemic disease ASA classification III or greater
- Concurrent use of any medication with severe interaction with Aprepitant as outlined in product monograph.
- Neuromuscular or congenital scoliosis
- Inability to take PO medications