Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT06357234
Status:
RECRUITING
Last Update Posted:
2025-03-25
First Post:
2024-01-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
Sponsor:
IWK Health Centre
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 .
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: