Using Aprepitant to Prevent Nausea in Children After Scoliosis Surgery
A Randomized Controlled Trial Comparing Aprepitant to Standard of Care for Postoperative Nausea and Vomiting Prophylaxis in Children and Adolescents Undergoing Scoliosis Surgery: The APRE-PONV Trial
This study tests if a medication called Aprepitant can help reduce nausea and vomiting in children after they have surgery for scoliosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 8 Years to 19 Years |
| Sex | All |
| Sponsor | IWK Health Centre Academic / other |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT06357234 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Aprepitant in reducing postoperative nausea and vomiting (PONV) in children undergoing surgery for scoliosis. It is a prospective, randomized, controlled trial that compares Aprepitant with a placebo as an addition to standard multimodal therapy. The primary focus is on the need for anti-nausea rescue medication after surgery, while secondary outcomes include various postoperative symptoms and adverse events. The study aims to provide insights into improving recovery experiences for pediatric patients undergoing spinal fusion.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 19 years who are undergoing posterior spinal instrumentation and fusion for idiopathic scoliosis.
Not a fit: Patients with hypersensitivity to Aprepitant, severe systemic diseases, or those unable to take oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of nausea and vomiting in children after scoliosis surgery, leading to improved recovery and comfort.
How similar studies have performed: Other studies have shown promising results with Aprepitant in preventing PONV in various surgical populations, suggesting potential success in this pediatric context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Halifax, Nova Scotia
- IWK Health Sciences Center — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: Mathew Kiberd, MD — IWK Health Centre
- Study coordinator: Mathew Kiberd, MD
- Email: mathew.kiberd@iwk.nshealth.ca
- Phone: 7789841329
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.