Jet-Injected Ketamine for Sedation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of administering the sedating medication ketamine using a jet-injection system, which delivers medication without needles. The aim is to determine if this method causes less pain and stress compared to other administration methods. It targets children undergoing simple procedures like blood draws or IV insertions. Children referred to the sedation clinic, weighing less than 40 kg and undergoing minimally invasive procedures, may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how this new treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I have to stop taking my current medications for the trial?
Yes, you may need to stop taking certain medications. If you are taking medications for sedation or those that affect how ketamine works, you might need to stop them before participating in the trial.
What prior data suggests that this jet-injection system is safe for sedation?
Research has shown that using a jet-injection system to administer ketamine is well-tolerated in children for anesthesia. This method causes little discomfort and poses fewer risks compared to traditional needle methods. Studies with both children and adults reported low pain levels, with no one rating pain higher than 1 on a scale from 0 to 10. This indicates that the jet-injection method is generally safe and does not cause significant pain. However, ketamine itself can have side effects, particularly depending on the dose, which may affect the brain, heart, and other areas. Discussing these effects with the trial team is important for those considering participation.12345
Why are researchers excited about this trial?
Researchers are excited about the jet-injected ketamine treatment because it offers a new, needle-free way to deliver sedation. Unlike traditional methods that use needles or oral medications, this system uses a high-pressure jet to administer ketamine quickly and painlessly through the skin. This could make the sedation process less stressful and more comfortable for patients, especially those who are needle-phobic. Additionally, the rapid delivery method might allow for faster onset of sedation, which can be crucial in emergency or urgent care settings.
What evidence suggests that this jet-injection system is effective for sedation?
Research has shown that using a jet injector to administer ketamine effectively calms patients, especially children. Studies have found that sedation begins more quickly with a jet injector than with other methods. Additionally, jet injector use for ketamine often results in less pain, with most individuals experiencing only mild discomfort. One study demonstrated that using a jet injector reduced the need to physically restrain patients during procedures, creating a smoother experience. This trial will evaluate the effectiveness of jet-injected ketamine, potentially offering a quicker and less painful method to calm patients.12367
Who Is on the Research Team?
Megan Peters, MD
Principal Investigator
University of Wisconsin, Madison
Are You a Good Fit for This Trial?
The Dreamy Jet Study is for children aged 2-15, weighing less than 40kg, who are visiting UW Health American Family Children's Hospital Pediatric Sedation Clinic for simple procedures like blood draws. It excludes those with high brain pressure, potential pregnancy, language barriers without a translator, uncontrolled high blood pressure, recent sedative use or certain medication interactions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of jet-injected ketamine for sedation before their procedure
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Jet-injection system
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Wisconsin, Madison
Lead Sponsor