Aprepitant for Postoperative Nausea and Vomiting

Overseen By Tristain Dumbarton, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: IWK Health Centre

Must not be taking: Severe interaction medications

Disqualifiers: Hypersensitivity to Aprepitant, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicine called Aprepitant, an anti-nausea drug, to determine if it can prevent nausea and vomiting in children undergoing surgery to correct scoliosis, a curvature of the spine. Participants will receive either Aprepitant or a placebo, a sugar-like solution without active medicine. Children with idiopathic scoliosis requiring surgery on at least six vertebrae and weighing over 40 kg may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using any medication that severely interacts with Aprepitant.

Is there any evidence suggesting that Aprepitant is likely to be safe for humans?

A previous study showed that aprepitant reduced the chances of nausea and vomiting after surgery. Research found that only about 15% of patients experienced vomiting, and 40% had nausea within 72 hours post-surgery. Another study revealed that only 6.8% of those who took aprepitant vomited, compared to 12.8% of those who did not.

Regarding safety, aprepitant is generally well-tolerated by patients. The FDA has already approved it for preventing nausea and vomiting caused by chemotherapy, indicating its safety for use. While this trial serves a different purpose, the existing approval provides some reassurance about its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for nausea and vomiting?

Aprepitant is unique because it specifically targets the neurokinin-1 (NK1) receptors, which play a key role in nausea and vomiting. Unlike standard treatments like ondansetron or metoclopramide that work by blocking serotonin or dopamine receptors, aprepitant offers a different mechanism of action by targeting the substance P pathway. This gives it the potential to be more effective for patients who don't respond well to existing medications. Researchers are excited about aprepitant because it might offer better protection against postoperative nausea and vomiting, especially in cases where other treatments fall short.

What evidence suggests that Aprepitant might be an effective treatment for postoperative nausea and vomiting?

Research has shown that aprepitant, which participants in this trial may receive, helps prevent nausea and vomiting after surgery. It is particularly effective in the first 24 hours, making it a strong option compared to other treatments. Studies found that aprepitant is more effective at stopping vomiting than nausea, with a high success rate. This may be due to its longer activity in the body. Overall, aprepitant has consistently demonstrated positive results in reducing nausea and vomiting after surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Mathew Kiberd, MD

Principal Investigator

IWK Health Centre

Are You a Good Fit for This Trial?

This trial is for children aged 8-18 undergoing scoliosis surgery to correct spinal curvature. They must weigh over 40kg and have a spinal fusion involving at least six vertebral levels. It's not suitable for those who don't meet these specific surgical or age requirements.

Inclusion Criteria

I had spinal surgery for scoliosis.

My spine surgery involved fusing 6 or more vertebrae together.

I weigh more than 40kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Aprepitant or placebo to prevent postoperative nausea and vomiting during scoliosis surgery

1 day

1 visit (in-person, surgery day)

Post-operative Monitoring

Participants are monitored for nausea, vomiting, and other adverse events post-surgery

Up to 10 days

Daily assessments (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aprepitant

Trial Overview

The study tests if Aprepitant can prevent nausea and vomiting after scoliosis surgery, compared with a placebo. Children will be randomly given either the drug or an inactive substance to see which works better.

How Is the Trial Designed?

Group I: Aprepitant Experimental Treatment 1 Intervention

Two doses of 40mg (2ml) Aprepitant

Group II: Dextrose Placebo Group 1 Intervention

Two doses of dextrose (2ml)

Who Is Running the Clinical Trial?

IWK Health Centre

Lead Sponsor

Trials

131

Recruited

112,000+

Published Research Related to This Trial

A population pharmacokinetic model for aprepitant was developed using data from 147 pediatric patients, showing that a weight-based dosing regimen for children under 12 and a fixed adult dose for adolescents effectively matches drug exposure levels seen in adults.

The study confirmed that aprepitant is effective for preventing chemotherapy-induced and postoperative nausea and vomiting in children and adolescents, supporting tailored dosing strategies for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. Chain, A., Wrishko, R., Vasilinin, G., et al.[2020]

Aprepitant, an antiemetic that blocks NK-1 receptors, was safely administered to 31 pediatric patients with a history or risk of postoperative nausea and vomiting (PONV), with no adverse effects reported.

In this cohort, PONV occurred in only 4 out of 31 patients, suggesting that aprepitant may be effective in reducing PONV, but further studies with larger sample sizes and comparisons to other treatments are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Administration of Emend&#174; (Aprepitant) at a Tertiary Care Children's Hospital: A 12-Month Survey. Kanaparthi, A., Kukura, S., Slenkovich, N., et al.[2022]

The aprepitant triple regimen significantly improves the prevention of chemotherapy-induced nausea and vomiting (CINV) compared to the standard regimen, showing better complete response rates in overall, acute, and delayed phases across 51 randomized controlled trials.

While aprepitant reduces the risk of constipation, it is associated with a higher incidence of hiccups, indicating a generally favorable safety profile with some manageable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiemetic regimen with aprepitant in the prevention of chemotherapy-induced nausea and vomiting: An updated systematic review and meta-analysis. Qiu, T., Men, P., Xu, X., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37478247/

The efficacy of aprepitant for the prevention ...

Further, administration of 80 mg aprepitant was better at preventing vomiting than nausea (OR: 8.6; 95% CI: 3.84, 19. 29; P < .00001). No ...

2.

journals.lww.com

journals.lww.com/md-journal/fulltext/2023/07210/the_efficacy_of_aprepitant_for_the_prevention_of.42.aspx

The efficacy of aprepitant for the prevention of... : Medicine

Most trials have found that aprepitant effectively delays postoperative nausea and vomiting. This may also be due to the longer half-life ...

3.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1481720/full

Enhanced efficacy of aprepitant-based triple prophylaxis in ...

Zhu et al.'s meta-analysis on the efficacy of aprepitant in preventing post-MBS nausea and vomiting suggested that aprepitant only reduced PONV ...

4.

dc.uthsc.edu

dc.uthsc.edu/dnp/120/

"Efficacy of Aprepitant and Ondansetron in Managing ...

The studies generally support the prediction of aprepitant's effectiveness in reducing post-operative nausea and vomiting, especially in the obese population.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1807593225002017

Aprepitant and fosaprepitant as a prophylactic antiemetic ...

Aprepitant, with a high level of evidence, is the most effective antiemetic for vomiting in the first 24 hours after surgery (Risk Ratio [RR] 0.26 (0.18‒0.38), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10662847/

The efficacy of aprepitant for the prevention of postoperative ...

Pooled results considered in the present analysis showed that aprepitant may better prevent vomiting than nausea and improve patient ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12335706/

The safety and efficacy of NEPA in preventing ...

Conclusions. NEPA demonstrated high efficacy and convenience, with vomiting occurring in only 15% of patients and nausea in 40% within 72 hours after surgery ...

8.

uptodate.com

uptodate.com/contents/postoperative-nausea-and-vomiting/abstract/150,151

Medline ® Abstracts for References 150,151 of 'Postoperative ...

On POD2, the rate of vomiting among patients receiving aprepitant was 6.8% compared with 12.8% for controls. The OR for vomiting compared with controls was 0.48 ...