Status:
RECRUITING
Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
Lead Sponsor:
IWK Health Centre
Conditions:
Spinal Fusion
Nausea and Vomiting, Postoperative
Eligibility:
All Genders
8-19 years
Phase:
PHASE2
Brief Summary
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).
Detailed 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-op...
Eligibility Criteria
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
Key Trial Info
Start Date :
March 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06357234
Start Date
March 17 2025
End Date
September 1 2027
Last Update
March 25 2025
Active Locations (1)
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1
IWK Health Sciences Center
Halifax, Nova Scotia, Canada, B3K 6R8