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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 19
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Canada
IWK Health Sciences Center
RECRUITING
Halifax
Contact Information
Primary
Mathew Kiberd, MD
mathew.kiberd@iwk.nshealth.ca
7789841329
Backup
Tristain Dumbarton, MD
tristan.dumbarton@iwk.nshealth.ca
9022401356
Time Frame
Start Date: 2025-03-17
Estimated Completion Date: 2027-09
Participants
Target number of participants: 100
Treatments
Experimental: Aprepitant
Two doses of 40mg (2ml) Aprepitant
Placebo_comparator: Dextrose
Two doses of dextrose (2ml)
Related Therapeutic Areas
Sponsors
Leads: IWK Health Centre