A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers.
C C Apfel, E Läärä, M Koivuranta...
https://pubmed.ncbi.nlm.nih.gov/10485781Actively Recruiting
Phase 2
Age: 8Years - 19Years
All Genders
ID06357234
A Randomized Controlled Trial Comparing Aprepitant to Standard Care for Preventing Postoperative Nausea and Vomiting in Children and Adolescents Undergoing Scoliosis Surgery
Led by IWK Health Centre · Updated on 2026-04-27
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research trial focuses on children and adolescents aged 8 to 18 years undergoing surgery to correct idiopathic scoliosis by posterior spinal instrumentation and fusion involving at least 6 vertebral levels. The study evaluates whether adding Aprepitant to the standard treatment can better prevent nausea and vomiting after surgery. It is a randomized, controlled trial aiming to reduce post-operative nausea and vomiting (PONV) and related symptoms like headache and pain, with careful monitoring of any side effects. Participants will receive either two doses of 40 mg Aprepitant syrup or two doses of a placebo (dextrose syrup). The first dose is given on the morning of surgery and the second on the morning after surgery (post-op day 1). This treatment is tested alongside the usual multimodal therapy used to prevent nausea and vomiting during and after surgery. During the study, researchers will track the need for anti-nausea rescue medication and record symptoms such as vomiting, headache, pain, flatus, bowel movements, and itching from the end of surgery until discharge, which may last up to 10 days. They will also watch for any treatment-related side effects. Participants will be closely monitored during their hospital stay to assess the effectiveness and safety of adding Aprepitant to standard care after scoliosis surgery.
CONDITIONS
Brief Title
Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
Who Can Participate
Age: 8Years - 19Years
All Genders
Eligibility Criteria
You may qualify if you...
- Posterior spinal instrumentation and fusion for idiopathic scoliosis
- Fusion includes at least 6 vertebral levels
- Children aged 8 to less than 19 years on the day of surgery
- Weight greater than 40 kilograms for dosing purposes
You will not qualify if you...
- Patient or parent refusal to participate
- Allergy or adverse reaction to Aprepitant or its ingredients
- Developmental delay as reported by parents
- Pregnancy (confirmed by pre-operative test)
- Severe systemic disease classified as ASA III or higher
- Use of medications that strongly interact with Aprepitant
- Neuromuscular or congenital scoliosis diagnosis
- Inability to take oral medications (by mouth)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Up to 2 days
Participants undergo scoliosis surgery and receive two doses of either Aprepitant or placebo: one on the morning of surgery and the second on the morning of post-operative day 1.
1 surgery day and 1 post-operative day visit
Post-operative Follow-up
Duration - Up to 10 days
Participants are monitored for up to 10 days after surgery to assess the incidence and severity of postoperative nausea and vomiting and other related symptoms, as well as treatment-emergent adverse events.
Daily visits or assessments during hospital stay up to discharge
Trial Site Locations
Total: 1 location
1
IWK Health Sciences Center
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
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Research Team
M
Mathew Kiberd, MD
T
Tristain Dumbarton, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting.
Tong J Gan, Kumar G Belani, Sergio Bergese...
https://pubmed.ncbi.nlm.nih.gov/32467512Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.
Stephanie Weibel, Gerta Rücker, Leopold Hj Eberhart...
https://pubmed.ncbi.nlm.nih.gov/33075160The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients.
L H J Eberhart, G Geldner, P Kranke...
https://pubmed.ncbi.nlm.nih.gov/15562045Who is at risk for postdischarge nausea and vomiting after ambulatory surgery?
Christian C Apfel, Beverly K Philip, Ozlem S Cakmakkaya...
https://pubmed.ncbi.nlm.nih.gov/22846680A prospective evaluation of the POVOC score for the prediction of postoperative vomiting in children.
Peter Kranke, Leopold H Eberhart, Hakki Toker...
https://pubmed.ncbi.nlm.nih.gov/18042855Aprepitant and fosaprepitant: a 10-year review of efficacy and safety.
Matti Aapro, Alexandra Carides, Bernardo L Rapoport...
https://pubmed.ncbi.nlm.nih.gov/25795636Pharmacokinetics and pharmacodynamics of aprepitant for the prevention of postoperative nausea and vomiting in pediatric subjects.
F Tansu Salman, Cara DiCristina, Anne Chain...
https://pubmed.ncbi.nlm.nih.gov/30381138Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind phase III trial in patients undergoing open abdominal surgery.
P Diemunsch, T J Gan, B K Philip...
https://pubmed.ncbi.nlm.nih.gov/17540667A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting.
Tong J Gan, Christian C Apfel, Anthony Kovac...
https://pubmed.ncbi.nlm.nih.gov/17456656