NCT06357234 Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
| NCT ID | NCT06357234 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | IWK Health Centre |
| Condition | Spinal Fusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-03-17 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Mathew Kiberd, MD
PRINCIPAL INVESTIGATOR
IWK Health Centre
Frequently Asked Questions
Who can join the NCT06357234 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 19 Years, studying Spinal Fusion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06357234 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06357234 currently recruiting?
Yes, NCT06357234 is actively recruiting participants. Contact the research team at mathew.kiberd@iwk.nshealth.ca for enrollment information.
Where is the NCT06357234 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT06357234 clinical trial?
NCT06357234 is sponsored by IWK Health Centre. The principal investigator is Mathew Kiberd, MD at IWK Health Centre. The trial plans to enroll 100 participants.