Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery

Last updated: March 21, 2025
Sponsor: IWK Health Centre
Overall Status: Active - Recruiting

Phase

2

Condition

Vomiting

Spine Athroplasty

Stomach Discomfort

Treatment

Placebo

Aprepitant

Clinical Study ID

NCT06357234
APRE-2023
  • Ages 8-19
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 dayof surgery

  • Weight > 40kg - for ease of pharmacy preparation (PONV dose 1mg per kg to max 40mg)

Exclusion

Exclusion Criteria:

  • Patient/ Parent refusal

  • Hypersensitivity to Aprepitant or any ingredient in the formulation or oralsolution. (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 outlinedin product monograph.

  • Neuromuscular or congenital scoliosis

  • Inability to take PO medications

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
March 17, 2025
Estimated Completion Date:
September 30, 2027

Study 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 .

Connect with a study center

  • IWK Health Sciences Center

    Halifax, Nova Scotia B3K 6R8
    Canada

    Active - Recruiting

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