Pharmacokinetics 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/30381138/Actively Recruiting
Led by IWK Health Centre · Updated on 2026-04-27
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
M
Mathew Kiberd, MD
T
Tristain Dumbarton, MD
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IWK Health Centre
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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