Recruiting
Phase 2

Aprepitant

Sponsor:

IWK Health Centre

Code:

NCT06357234

Conditions

Spinal Fusion

Nausea and Vomiting, Postoperative

Anesthesia

Eligibility Criteria

Sex: All

Age: 8 - 19

Healthy Volunteers: Not accepted

Interventions

Aprepitant

Placebo

Study Details

Brief 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).

Conditions

Spinal Fusion

Nausea and Vomiting, Postoperative

Anesthesia

Study ID

NCT06357234

Start date

Mar 17, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 19

Healthy Volunteers: Not accepted

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Aprepitant

Two doses of 40mg (2ml) Aprepitant

placebo comparator: Dextrose

Two doses of dextrose (2ml)

Interventions

Aprepitant

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

Placebo

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

Primary outcome measure

  • Anti-Nausea Rescue Medication [ Time Frame: From surgery end-time until discharge, estimated period of up to 10 days ]

Central Contacts and Locations

Central contacts

Mathew Kiberd, MD

7789841329mathew.kiberd@iwk.nshealth.ca

Tristain Dumbarton, MD

9022401356tristan.dumbarton@iwk.nshealth.ca

Locations

IWK Health Sciences Center

Recruiting

Halifax, Nova Scotia, Canada, B3K 6R8

Contacts

Primary Investigator, MD FRCPC

9024708888mathew.kiberd@iwk.nshealth.ca

Co-PI, MD FRCPC

9024708888tristan.dumbarton@iwk.nshealth.ca

Principal Investigator:

Mathew B Kiberd, MD FRCPC

More Information

Sponsor

IWK Health Centre

Last update posted

Apr 27, 2026

Last verified

Mar, 2026

Keywords

  • pediatric
  • anesthetic
  • scoliosis
  • Aprepitant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by IWK Health Centre on 2026-04-27.