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

IWK Health Centre

Status and phase: Enrolling; Phase 2

Conditions: Spinal Fusion; Anesthesia; Nausea and Vomiting, Postoperative

Treatments: Drug: Placebo; Drug: Aprepitant

Study type: Interventional

Funder types: Other

Identifiers

NCT06357234

APRE-2023

Details and patient eligibility

About

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).

Full 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 .

Enrollment: 100 estimated patients

Sex: All

Ages: 8 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

Aprepitant

Experimental group

Description:

Two doses of 40mg (2ml) Aprepitant

Treatment:

Drug: Aprepitant

Dextrose

Placebo Comparator group

Description:

Two doses of dextrose (2ml)

Treatment:

Drug: Placebo