Aprepitant Treatment to Prevent Postoperative Nausea and Vomiting in Children Undergoing Scoliosis Surgery
NCT ID: NCT06357234
Last Updated: 2025-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2025-03-17
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Aprepitant
Two doses of 40mg (2ml) Aprepitant
Aprepitant
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
Dextrose
Two doses of dextrose (2ml)
Placebo
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
Interventions
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Aprepitant
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
Placebo
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
19 Years
ALL
No
Sponsors
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IWK Health Centre
OTHER
Responsible Party
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Principal Investigators
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Mathew Kiberd, MD
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Locations
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IWK Health Sciences Center
Halifax, Nova Scotia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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APRE-2023
Identifier Type: -
Identifier Source: org_study_id
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