Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age8-19
SponsorIWK Health Centre
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Aprepitant
DrugTwo 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
Placebo
DrugTwo 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
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: AprepitantExperimental treatment 1 intervention
Group B: DextrosePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anti-Nausea Rescue Medication
Anti-nausea rescue medication administered (yes/no).
Time frame
From surgery end-time until discharge, estimated period of up to 10 daysSecondary outcomes
1
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 days2
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 days3
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 days4
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 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov