NCT06357234

Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing 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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: IWK Health Centre · Academic / Other
• Sex: All
• Age: 8 Years – 19 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Detailed Description: This prospective, randomized, controlled trial will test whether adding Aprepitant to standard multimodal therapy regimen can further reduce the incidence and severity of post-operative nausea and vomiting (PONV) in children undergoing posterior spinal instrumentation and fusion. The primary outcome of the study will be anti-nausea rescue medication administration post-surgery, with secondary outcomes being the first instance of post-surgery anti-nausea rescue medication administration, emesis, headache, flatus, bowel movement, and sensation of itch; incidence of treatment-emergent adverse events; and worst nausea and pain scores post-surgery .

Conditions

• Spinal Fusion
• Nausea and Vomiting, Postoperative
• Anesthesia

Interventions

Type	Name	Description
DRUG	Aprepitant	Two doses of 40mg (2ml) Aprepitant. One to be given on the morning of surgery and the second on the morning of post-op day 1
DRUG	Placebo	Two doses of dextrose syrup (2ml). One to be given on the morning of surgery and the second on the morning of post-op day 1

Timeline

• Start date: 2025-03-17
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2024-04-10
• Last updated: 2025-03-25

Locations

1 site across 1 country: Canada