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

NCT06357234 | Recruiting Phase 2 DMC

• 1 other identifier: APRE-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Fusion; Anesthesia; Nausea and Vomiting, Postoperative

Keywords

pediatric; anesthetic; scoliosis; Aprepitant

Outcome Measures

Primary Outcomes (1)

• Anti-Nausea Rescue Medication

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

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

Secondary Outcomes (9)

• 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

• 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

• Baxter Retching Faces score

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

• Pain score

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

• 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

Study Arms (2)

Aprepitant

EXPERIMENTAL

Two doses of 40mg (2ml) Aprepitant

Drug: Aprepitant

Dextrose

PLACEBO COMPARATOR

Two doses of dextrose (2ml)

Drug: Placebo

Interventions

Aprepitant DRUG

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

Also known as: Aprepitant oral suspension 20mg/ml

Aprepitant

Placebo DRUG

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

Also known as: Dextrose

Dextrose

Eligibility Criteria

• Age: 8 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Sciences Center

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (13)

• 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.

  PMID: 10485781 BACKGROUND

• 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.

  PMID: 32467512 BACKGROUND

• 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.

  PMID: 33075160 BACKGROUND

• 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.

  PMID: 15562045 BACKGROUND

• 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.

  PMID: 22846680 BACKGROUND

• 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.

  PMID: 18042855 BACKGROUND

• 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.

  PMID: 25795636 BACKGROUND

• 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.

  PMID: 30381138 BACKGROUND

• 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.

  PMID: 17540667 BACKGROUND

• 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.

  PMID: 17456656 BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 20332509 BACKGROUND

• 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.

  PMID: 31094795 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Scoliosis

Interventions

Aprepitant; Glucose

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Mathew Kiberd, MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathew Kiberd, MD

CONTACT

7789841329; mathew.kiberd@iwk.nshealth.ca

Tristain Dumbarton, MD

CONTACT

9022401356; tristan.dumbarton@iwk.nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment arm of participants will be masked until data collection is complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized double-blind placebo controlled study

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: April 10, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)