Injectable Medication Platforms for Medical Treatments

Overseen By Sean Meredith, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Canadian Forces Health Services Centre Ottawa

Disqualifiers: Cognitive impairment, Manual dexterity issues, Substance use, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Background: While medical advances for in-hospital care rapidly evolve, a mainstay of effective pre-hospital care remains the ability to treat medical emergencies such as anaphylaxis, prolonged seizure, overdose, or uncontrolled bleeding, through rapid administration of appropriate medication. Autoinjectors are used globally to deliver medications in a timely manner, often in environments where immediate access to medical facilities is limited. Rapid administration of intramuscular medication delivery is essential where oral or intravenous delivery is either not possible or ineffective. The purpose of the proposed study seeks to determine the efficiency various types of medication injection administration.

Who Is on the Research Team?

Gaurav Gupta, MD

Principal Investigator

CAF

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent and have not used medication injections in the past year. It's not for healthcare workers with recent injection experience or those with conditions affecting thinking or hand coordination, as well as anyone with recent substance use.

Exclusion Criteria

Recent substance use

Participants with pre-specified conditions impacting cognitive and/or manual dexterity

I have given myself or someone else an injection in the past year, and I am not a healthcare worker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Injection Scenarios

Participants administer injections using various methods: standard protocol, autoinjector, and pre-filled syringes.

1-2 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for any injection failures, injuries, and perceived difficulty of injection methods.

immediately after intervention

What Are the Treatments Tested in This Trial?

Interventions

• Assessment of Injectable Medication Platforms
• Autoinjector
• Prefilled
• Standard Injector

Trial Overview The study compares different methods of injecting emergency medications: autoinjectors, standard injectors, and prefilled syringes. The goal is to find out which method delivers medicine most efficiently during emergencies like severe allergies or overdoses.

How Is the Trial Designed?

Group I: Injection Scenario Experimental Treatment 3 Interventions

For each scenario participants will be asked to administer/inject the "medication" (likely saline or air) using various methods: 1) standard protocol , 2) Autoinjector 3) Pre-filled syringes. For each scenario the appropriate medication administration type will have to be selected amongst groups of options: 1) autoinjectors equivalents (ie medication, needle and syringe attached) 2) prefilled syringes where a needle is attached prior to administration; and 3) standard protocol (i.e. drawing medication from the vial and injecting via syringe/22 gauge needle). Medications options will include 1) Naloxone (opioid overdose) 2) Epinephrine (anaphylaxis) 3) Tranexamic acid (bleeding).

Who Is Running the Clinical Trial?

Canadian Forces Health Services Centre Ottawa

Lead Sponsor

Trials

10

Recruited

1,200+