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

Trial Summary

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.

What data supports the effectiveness of the drug aprepitant for preventing postoperative nausea and vomiting?

Research shows that aprepitant significantly reduces vomiting on the first and second days after surgery compared to other treatments, with fewer patients needing additional medication to control symptoms. ^{1 2 3 4 5}

Is aprepitant safe for humans?

Aprepitant is generally considered safe for humans, as studies show it effectively prevents nausea and vomiting after surgery without major adverse effects. ^{1 2 5 6 7}

How is the drug aprepitant unique for treating postoperative nausea and vomiting?

Aprepitant is unique because it works by blocking neurokinin-1 (NK-1) receptors, which is different from many other treatments that target serotonin receptors. It has been shown to provide better protection against vomiting and has a longer-lasting effect, reducing the need for additional medication after surgery. ^{1 3 4 7 8}

What is the purpose of 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).

Research Team

Mathew Kiberd, MD

Principal Investigator

IWK Health Centre

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Aprepitant for postoperative nausea and vomiting: a systematic review and meta-analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and pharmacodynamics of aprepitant for the prevention of postoperative nausea and vomiting in pediatric subjects. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Preventing postoperative nausea and vomiting: post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Perioperative Administration of Emend&#174; (Aprepitant) at a Tertiary Care Children's Hospital: A 12-Month Survey. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The efficacy of aprepitant for the prevention of postoperative nausea and vomiting: A meta-analysis. [2023]

6. United States 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. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Modeling and Simulation Analysis of Aprepitant Pharmacokinetics in Pediatric Patients With Postoperative or Chemotherapy-Induced Nausea and Vomiting. [2020]

8. Japan pubmed.ncbi.nlm.nih.gov

Neurokinin-1 receptor antagonism, aprepitant, effectively diminishes post-operative nausea and vomiting while increasing analgesic tolerance in laparoscopic gynecological procedures. [2022]