Anesthesia, Nausea and Vomiting, Postoperative, Spinal Fusion
Conditions
Keywords
pediatric, anesthetic, scoliosis, Aprepitant
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 .
Interventions
DRUGAprepitant
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
DRUGPlacebo
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
Sponsors
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Treatment arm of participants will be masked until data collection is complete.
Intervention model description
This is a randomized double-blind placebo controlled study
Eligibility
Sex/Gender
ALL
Age
8 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Nausea Rescue Medication | From surgery end-time until discharge, estimated period of up to 10 days | Anti-nausea rescue medication administered (yes/no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-nausea rescue medication administered by 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 | 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. |
| Emesis (Yes/No) | 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 |
| Baxter Retching Faces score | 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). |
| Pain score | 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). |
| Headache (yes/no) | 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 |
| Flatus (yes/no) | 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 |
| Bowel Motility (yes/no) | 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 |
| Sensation of Itch | 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 |
| Treatment of emergent adverse events | 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 |
Countries
Canada
Contacts
CONTACTMathew Kiberd, MD
CONTACTTristain Dumbarton, MD
PRINCIPAL_INVESTIGATORMathew Kiberd, MD
IWK Health Centre
Outcome results
None listed