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New treatment option for Spinal Fusion
Official title Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
ClinicalTrials.gov ID: NCT06357234
What this study is testing
What is Aprepitant?
Aprepitant is an investigational medicine, being studied as a potential treatment for spinal fusion.
Also referred to as Aprepitant oral suspension 20mg/ml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 19
You may be able to join if
- 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)
You likely can't join if
- 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.
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.