Clinical trial NCT06357234: Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Spinal Fusion
Nausea and Vomiting, Postoperative
Anesthesia
Keywords: pediatric
anesthetic
scoliosis
Aprepitant
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized double-blind placebo controlled study
Primary purpose: PREVENTION

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).

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 .

Eligibility criteria: 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

Primary outcomes:
measure: Anti-Nausea Rescue Medication
timeFrame: From surgery end-time until discharge, estimated period of up to 10 days
Secondary outcomes:
measure: Anti-nausea rescue medication administered by post-operative day
timeFrame: 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
measure: Emesis (Yes/No)
timeFrame: 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
measure: Baxter Retching Faces score
timeFrame: From surgery end time until discharge,estimated period of up to 10 days
measure: Pain score
timeFrame: From surgery end time until discharge, estimated period of up to 10 days
measure: Headache (yes/no)
timeFrame: 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
measure: Flatus (yes/no)
timeFrame: 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
measure: Bowel Motility (yes/no)
timeFrame: 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
measure: Sensation of Itch
timeFrame: 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
measure: Treatment of emergent adverse events
timeFrame: From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Sciences Center
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Mathew Kiberd, MD
role: PRINCIPAL_INVESTIGATOR
References:
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