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Recruiting Phase 2 NCT06357234

Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery

◆ AI Clinical Summary

This study tests whether a medication called Aprepitant can help prevent nausea and vomiting after surgery to straighten the spine (scoliosis surgery) in children. Nausea and vomiting are common side effects after surgery, and this medicine may help reduce these uncomfortable symptoms.

Key Objective: The trial is testing whether Aprepitant can effectively reduce nausea and vomiting that commonly occur after spinal fusion surgery in children.

Who to Consider: Children who are scheduled to undergo scoliosis surgery and are concerned about post-operative nausea and vomiting should consider enrolling in this study.

Trial Parameters

Condition Spinal Fusion
Sponsor IWK Health Centre
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 100
Sex ALL
Min Age 8 Years
Max Age 19 Years
Start Date 2025-03-17
Completion 2027-03
Interventions
AprepitantPlacebo

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).

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

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