Jet-Injected Ketamine for Sedation

Overseen By Research Nurses

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Wisconsin, Madison

Must not be taking: Benzodiazepines, Opioids, Antihistamines, others

Disqualifiers: Pregnancy, Hypertension, Intracranial pressure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Jet-Injected Ketamine for Sedation?

Research shows that jet-injected ketamine has been used effectively for anesthetic induction in children, reducing the need for physical restraint and minimizing discomfort compared to traditional needle injections. Additionally, needle-free systems like jet injection are considered to have fewer risks and lower costs, making them a valuable option for pediatric sedation. ^{1 2 3 4 5}

Is jet-injected ketamine safe for use in humans?

Jet-injected ketamine has been used safely in children for anesthesia, with reports suggesting minimal discomfort and lower risks compared to traditional needle injections. Further studies are needed to confirm these findings and explore other uses. ^{1 2 3 6 7}

How is jet-injected ketamine different from other sedation drugs?

Jet-injected ketamine is unique because it uses a needle-free system to deliver the drug, which can reduce pain and psychological trauma associated with traditional needle injections, especially in children. This method is considered to have fewer risks and is more comfortable compared to standard syringe and needle approaches. ^{1 2 3 4 8}

What is the purpose of this trial?

The goal of this clinical trial is to see if a device known as a jet-injection system can help deliver a single dose of a sedating medication with less pain and stress than current methods. Participants will receive a dose of the sedative in their arm or thigh before their procedure at the sedation clinic.

Research Team

Megan Peters, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

I am between 2 and 15 years old.

I am referred to a specific clinic for simple procedures like blood tests or shots.

I weigh less than 40kg.

Exclusion Criteria

I have high pressure inside my skull.

Participants who are pregnant or possibly pregnant (i.e., people of child bearing potential unable to provide a negative pregnancy test)

My parent or guardian needs a translator for medical discussions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of jet-injected ketamine for sedation before their procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

Up to 3 hours

Treatment Details

Interventions

• Jet-injection system

Trial Overview This study tests if a jet-injection system can deliver Ketamine—a sedative—more comfortably before minor procedures. Participants will receive the sedative in their arm or thigh to assess pain and stress levels compared to traditional methods.

Participant Groups

Group I: J-tip jet injection Experimental Treatment 1 Intervention

Participants will be given ketamine via J-tip jet injection

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

Jet-injection of ketamine (K) for anesthetic induction in 30 children aged 1-6 years was found to be effective and pain-free, eliminating the need for physical restraint during the procedure.

The study indicated that a lower dose of 3.5 mg/kg of ketamine is sufficient for routine use, as the higher dose of 6.0 mg/kg increased the risk of laryngospasm without providing additional benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new route, jet-injection for anesthetic induction in children - II. ketamine dose-range finding studies. Zsigmond, EK., Kovacs, V., Fekete, G.[2013]

Intravenous ketamine dosing for procedural sedation in children varies by age, with recommended single bolus doses of 1.5 to 2.125 mg/kg, but larger doses can lead to deeper sedation and slower recovery times.

Using a smaller initial dose followed by a 'top-up' or continuous infusion can achieve the desired sedation level more effectively, with quicker recovery times, highlighting the importance of tailoring doses based on individual patient needs and the type of pain management required.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dosing ketamine for pediatric procedural sedation in the emergency department. Dallimore, D., Herd, DW., Short, T., et al.[2022]

Ketamine is considered very safe, making it a preferred choice for sedation in children and in veterinary medicine, with low rates of serious complications from intentional overdose.

Most risks associated with ketamine use arise from accidents during its recreational use, particularly due to the potential for vomiting and aspiration in deeply sedated individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine as a street drug. Stewart, CE.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

A new route, jet-injection for anesthetic induction in children - II. ketamine dose-range finding studies. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

'Needle-free' delivery of local anesthesia: a valuable option in pediatrics. [2018]

3. Singapore pubmed.ncbi.nlm.nih.gov

A comparative evaluation of drops versus atomized administration of intranasal ketamine for the procedural sedation of young uncooperative pediatric dental patients: a prospective crossover trial. [2022]

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

Dosing ketamine for pediatric procedural sedation in the emergency department. [2022]

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

High-Dose Ketamine Sedation of an Agitated Patient During Air Medical Transport. [2017]

6. Iran pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial of Intravenous and Intramuscular Ketamine for Pediatric Procedural Sedation and Analgesia. [2022]

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

Ketamine as a street drug. [2019]

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

Measurement of ketamine and xylazine in rat brain by liquid-liquid extraction and gas chromatography-mass spectrometry. [2015]