IWK Health Sciences Center
Halifax, Nova Scotia, B3K 6R8, Canada
Location status: Recruiting
Location contact
Co-PI, MD FRCPC
CONTACT
Mathew B Kiberd, MD FRCPC
PRINCIPAL_INVESTIGATOR
Primary Investigator, MD FRCPC
CONTACT
NCT Number: NCT06357234
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).
Interested in participating?
Request Info8 year–19 year
All sexes
Interventional
Phase 2
Halifax, Nova Scotia, B3K 6R8, Canada
Location status: Recruiting
Co-PI, MD FRCPC
CONTACT
Mathew B Kiberd, MD FRCPC
PRINCIPAL_INVESTIGATOR
Primary Investigator, MD FRCPC
CONTACT
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Aprepitant oral suspension 20mg/ml
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
Other names: Dextrose
Time frame: From surgery end-time until discharge, estimated period of up to 10 days
Anti-nausea rescue medication administered (yes/no).
Time frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Anti-nausea rescue medication administered (yes/no). Assessed each post-operative day. The primary outcome is whether nausea rescue medication is used at all in the post-operative period. The secondary outcome is the time (By post operative day) when the first rescue medication is administered.
Time frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Assessed each post operative day
Time frame: From surgery end time until discharge,estimated period of up to 10 days
Baxter Retching Faces (BARF) scale of nausea - worst score collected twice per post-operative day. Scores range from 0 to 10. Higher scores indicate a worse outcome (0=no nausea at all, 10=the most nausea it is possible to feel).
Time frame: From surgery end time until discharge, estimated period of up to 10 days
Faces pain scale revised - worst score. Collected twice per post-operative day Faces pain scale-revised: Score of 0 to 10. Higher scores indicate a worse outcome (0=no pain, 10=very much pain).
Time frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Recorded as headache (yes/No) Assessed each post-operative day
Time frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Assessed each post-operative day
Time frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Assessed each post-operative day
Time frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Assessed each post-operative day
Time frame: From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days
Assessed each day from time of administration of study drug or placebo
Contact information is provided by the study sponsor or research team.
Mathew Kiberd, MD
CONTACT
Tristain Dumbarton, MD
CONTACT
IWK Health Centre
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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