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: 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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
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
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
IWK Health Sciences Center
Halifax, Nova Scotia, Canada
RECRUITINGAnti-Nausea Rescue Medication
Anti-nausea rescue medication administered (yes/no).
Time frame: From surgery end-time until discharge, estimated period of up to 10 days
Anti-nausea rescue medication administered by post-operative day
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.
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
Emesis (Yes/No)
Assessed each 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
Baxter Retching Faces score
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).
Time frame: From surgery end time until discharge,estimated period of up to 10 days
Pain score
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).
Time frame: From surgery end time until discharge, estimated period of up to 10 days
Headache (yes/no)
Recorded as headache (yes/No) Assessed each post-operative day
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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
Flatus (yes/no)
Assessed each 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
Bowel Motility (yes/no)
Assessed each 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
Sensation of Itch
Assessed each 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
Treatment of emergent adverse events
Assessed each day from time of administration of study drug or placebo
Time frame: From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days