RecruitingPhase 2NCT06357234

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


Sponsor

IWK Health Centre

Enrollment

100 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 8 YearsMax Age: 19 Years

Inclusion Criteria4

  • Posterior Spinal Instrumentation and Fusion (PSIF) for idiopathic scoliosis
  • The fusion must include at least 6 vertebral levels.
  • Children greater than or equal to 8 years old, and less than 19 years old on the day of surgery
  • Weight \> 40kg - for ease of pharmacy preparation (PONV dose 1mg per kg to max 40mg)

Exclusion Criteria8

  • Patient/ Parent refusal
  • Hypersensitivity to Aprepitant or any ingredient in the formulation or oral solution. (previous allergy or adverse reaction to Aprepitant)
  • Developmental delay as reported by parents
  • Pregnant - Pregnancy test done as standard of care pre-operative
  • Severe systemic disease ASA classification III or greater
  • Concurrent use of any medication with severe interaction with Aprepitant as outlined in product monograph.
  • Neuromuscular or congenital scoliosis
  • Inability to take PO medications

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Interventions

DRUGAprepitant

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

DRUGPlacebo

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


Locations(1)

IWK Health Sciences Center

Halifax, Nova Scotia, Canada

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NCT06357234


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