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NCT Number: NCT06357234

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

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).

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Key information

Age range

8 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Health Sciences Center

Halifax, Nova Scotia, B3K 6R8, Canada

Location status: Recruiting

Location contact

Co-PI, MD FRCPC

CONTACT

[email protected]

9024708888

Mathew B Kiberd, MD FRCPC

PRINCIPAL_INVESTIGATOR

Primary Investigator, MD FRCPC

CONTACT

[email protected]

9024708888

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

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

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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).

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mathew Kiberd, MD

CONTACT

[email protected]

7789841329

Tristain Dumbarton, MD

CONTACT

[email protected]

9022401356

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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