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Spinal FusionPhase 2NCT06357234

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

A Phase 2 study testing Aprepitant in people with Spinal Fusion and Nausea and Vomiting, Postoperative, run by IWK Health Centre at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 8 to 19 years
What is being tested?
Aprepitant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteCanada
Study dates
17 Mar 2025to Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tristain Dumbarton, MD contact

9022401356

tristan.dumbarton@iwk.nshealth.ca

Canada1 site, 1 recruiting
  • IWK Health Sciences Center

    Halifax, Nova Scotia, B3K 6R8

    Primary Investigator, MD FRCPC, 9024708888, mathew.kiberd@iwk.nshealth.ca

    Co-PI, MD FRCPC, 9024708888, tristan.dumbarton@iwk.nshealth.ca

    Recruiting

Other trials in Canada

About this study

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

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).

Read the 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 .

Being tested
Aprepitant, Placebo
Keywords
pediatric, anesthetic, scoliosis, Aprepitant
Medical subject headings
Postoperative Nausea and Vomiting, Scoliosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AprepitantDrug

    Also called Aprepitant oral suspension 20mg/ml

    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

  • PlaceboDrug

    Also called Dextrose

    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

Study groups in NCT06357234
Study groupRoleWhat they receive
AprepitantExperimentalTwo doses of 40mg (2ml) Aprepitant
Receives: Drug: Aprepitant
DextrosePlacebo comparatorTwo doses of dextrose (2ml)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-Nausea Rescue Medication

    Anti-nausea rescue medication administered (yes/no).

    Measured: From surgery end-time until discharge, estimated period of up to 10 days

Secondary outcomes (9)
  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.

    Measured: 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

  2. Emesis (Yes/No)

    Assessed each post operative day

    Measured: 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

  3. 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).

    Measured: From surgery end time until discharge,estimated period of up to 10 days

  4. 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).

    Measured: From surgery end time until discharge, estimated period of up to 10 days

  5. Headache (yes/no)

    Recorded as headache (yes/No) Assessed each post-operative day

    Measured: 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

  6. Flatus (yes/no)

    Assessed each post-operative day

    Measured: 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

  7. Bowel Motility (yes/no)

    Assessed each post-operative day

    Measured: 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

  8. Sensation of Itch

    Assessed each post-operative day

    Measured: 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

  9. Treatment of emergent adverse events

    Assessed each day from time of administration of study drug or placebo

    Measured: From administration of first dose of study drug (or placebo) to discharge],estimated period of up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2024
  2. Study start17 Mar 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a randomized double-blind placebo controlled study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06357234
Sponsor's protocol ID
APRE-2023
Status last verified
Mar 2026
First submitted
17 Jan 2024
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

    PubMed 10485781
  • Gan TJ, Belani KG, Bergese S, Chung F, Diemunsch P, Habib AS, Jin Z, Kovac AL, Meyer TA, Urman RD, Apfel CC, Ayad S, Beagley L, Candiotti K, Englesakis M, Hedrick TL, Kranke P, Lee S, Lipman D, Minkowitz HS, Morton J, Philip BK. Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting. Anesth Analg. 2020 Aug;131(2):411-448. doi: 10.1213/ANE.0000000000004833.

    PubMed 32467512
  • Weibel S, Rucker G, Eberhart LH, Pace NL, Hartl HM, Jordan OL, Mayer D, Riemer M, Schaefer MS, Raj D, Backhaus I, Helf A, Schlesinger T, Kienbaum P, Kranke P. Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis. Cochrane Database Syst Rev. 2020 Oct 19;10(10):CD012859. doi: 10.1002/14651858.CD012859.pub2.

    PubMed 33075160
  • Eberhart LHJ, Geldner G, Kranke P, Morin AM, Schauffelen A, Treiber H, Wulf H. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth Analg. 2004 Dec;99(6):1630-1637. doi: 10.1213/01.ANE.0000135639.57715.6C.

    PubMed 15562045
  • Apfel CC, Philip BK, Cakmakkaya OS, Shilling A, Shi YY, Leslie JB, Allard M, Turan A, Windle P, Odom-Forren J, Hooper VD, Radke OC, Ruiz J, Kovac A. Who is at risk for postdischarge nausea and vomiting after ambulatory surgery? Anesthesiology. 2012 Sep;117(3):475-86. doi: 10.1097/ALN.0b013e318267ef31.

    PubMed 22846680
  • Kranke P, Eberhart LH, Toker H, Roewer N, Wulf H, Kiefer P. A prospective evaluation of the POVOC score for the prediction of postoperative vomiting in children. Anesth Analg. 2007 Dec;105(6):1592-7, table of contents. doi: 10.1213/01.ane.0000287816.44124.03.

    PubMed 18042855
  • Aapro M, Carides A, Rapoport BL, Schmoll HJ, Zhang L, Warr D. Aprepitant and fosaprepitant: a 10-year review of efficacy and safety. Oncologist. 2015 Apr;20(4):450-8. doi: 10.1634/theoncologist.2014-0229. Epub 2015 Mar 20.

    PubMed 25795636
  • Salman FT, DiCristina C, Chain A, Afzal AS. Pharmacokinetics and pharmacodynamics of aprepitant for the prevention of postoperative nausea and vomiting in pediatric subjects. J Pediatr Surg. 2019 Jul;54(7):1384-1390. doi: 10.1016/j.jpedsurg.2018.09.006. Epub 2018 Sep 21.

    PubMed 30381138
  • Diemunsch P, Gan TJ, Philip BK, Girao MJ, Eberhart L, Irwin MG, Pueyo J, Chelly JE, Carides AD, Reiss T, Evans JK, Lawson FC; Aprepitant-PONV Protocol 091 International Study Group. Single-dose aprepitant vs ondansetron for the prevention of postoperative nausea and vomiting: a randomized, double-blind phase III trial in patients undergoing open abdominal surgery. Br J Anaesth. 2007 Aug;99(2):202-11. doi: 10.1093/bja/aem133. Epub 2007 May 30.

    PubMed 17540667
  • Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC; Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007 May;104(5):1082-9, tables of contents. doi: 10.1213/01.ane.0000263277.35140.a3.

    PubMed 17456656
  • Hasan AME, Abdelzaam E-S. A comparative study between Aprepitant only versus combined ondansetron and Aprepitant as antiemetic therapy, regarding efficacy and duration, in patients undergoing laparoscopic bariatric surgery double-blinded, randomized control clinical trial. J Anesth Clin Res. 2019;10(5)

  • Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.

    PubMed 20332509
  • Watcha MF, Lee AD, Medellin E, Felberg MT, Bidani SA. Clinical Use of the Pictorial Baxter Retching Faces Scale for the Measurement of Postoperative Nausea in Children. Anesth Analg. 2019 Jun;128(6):1249-1255. doi: 10.1213/ANE.0000000000003850.

    PubMed 31094795

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aprepitant in people with Spinal Fusion and Nausea and Vomiting, Postoperative, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mathew Kiberd, MD (7789841329, mathew.kiberd@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-Nausea Rescue Medication (time frame: From surgery end-time until discharge, estimated period of up to 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06357234, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.

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