Aprepitant for Postoperative Nausea and Vomiting
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.12345Why 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.24678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Aprepitant or placebo to prevent postoperative nausea and vomiting during scoliosis surgery
Post-operative Monitoring
Participants are monitored for nausea, vomiting, and other adverse events post-surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aprepitant
Find a Clinic Near You
Who Is Running the Clinical Trial?
IWK Health Centre
Lead Sponsor