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

April 22, 2026 updated by: IWK Health Centre

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 .

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aprepitant
Two doses of 40mg (2ml) Aprepitant
Drug: 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
Other Names:
  • Aprepitant oral suspension 20mg/ml
Placebo Comparator: Dextrose
Two doses of dextrose (2ml)
Drug: 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
Other Names:
  • Dextrose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Nausea Rescue Medication
Time Frame: From surgery end-time until discharge, estimated period of up to 10 days
Anti-nausea rescue medication administered (yes/no).
From surgery end-time until discharge, estimated period of up to 10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-nausea rescue medication administered by post-operative day
Time Frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Anti-nausea rescue medication administered (yes/no). Assessed each post-operative day. The primary outcome is whether nausea rescue medication is used at all in the post-operative period. The secondary outcome is the time (By post operative day) when the first rescue medication is administered.
From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Emesis (Yes/No)
Time Frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Assessed each post operative day
From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Baxter Retching Faces score
Time Frame: From surgery end time until discharge,estimated period of up to 10 days
Baxter Retching Faces (BARF) scale of nausea - worst score collected twice per post-operative day. Scores range from 0 to 10. Higher scores indicate a worse outcome (0=no nausea at all, 10=the most nausea it is possible to feel).
From surgery end time until discharge,estimated period of up to 10 days
Pain score
Time Frame: From surgery end time until discharge, estimated period of up to 10 days
Faces pain scale revised - worst score. Collected twice per post-operative day Faces pain scale-revised: Score of 0 to 10. Higher scores indicate a worse outcome (0=no pain, 10=very much pain).
From surgery end time until discharge, estimated period of up to 10 days
Headache (yes/no)
Time Frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Recorded as headache (yes/No) Assessed each post-operative day
From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Flatus (yes/no)
Time Frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Assessed each post-operative day
From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period), estimated period of up to 10 days
Bowel Motility (yes/no)
Time Frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Assessed each post-operative day
From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Sensation of Itch
Time Frame: From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Assessed each post-operative day
From surgery end-time until first instance (yes) or until discharge (if no instances during post-operative period),estimated period of up to 10 days
Treatment of emergent adverse events
Time Frame: From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days
Assessed each day from time of administration of study drug or placebo
From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Mathew Kiberd, MD, IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APRE-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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