Assessment of Injectable Medication Platforms

NCT05367531 | Unknown

• 1 other identifier: 2020-046
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overdose Antidote; Bleeding; Allergic Reaction

Keywords

autoinjector; needle; syringe; medication

Outcome Measures

Primary Outcomes (1)

• Change in medication Injection/delivery time for each trial

  Time in seconds will be measured from the start of the scenario and stopped once the medication has been delivered to the orange.

  immediately after intervention

Secondary Outcomes (2)

• Number of injection failures and/or injuries associated with each trial

  immediately after intervention

• Perceived difficulty of injection based on type of system

  immediately after intervention

Study Arms (1)

Injection Scenario

EXPERIMENTAL

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).

Device: Autoinjector; Device: Standard Injector; Device: Prefilled

Interventions

Autoinjector DEVICE

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). The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Injection Scenario

Standard Injector DEVICE

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). The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Injection Scenario

Prefilled DEVICE

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). The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).

Injection Scenario

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any participant over the age of 18 able to provide consent

You may not qualify if:

• only participants with pre specified conditions impacting cognitive and/or manual dexterity will be excluded
• recent substance use
• non health care workers injection with experience with medication injection in last 12 months

Sponsors & Collaborators

• Canadian Forces Health Services Centre Ottawa: lead

Study Sites (1)

Canadian Forces

Ottawa, Ontario, K1K 0T2, Canada

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Hypersensitivity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Officials

• Gaurav Gupta, MD

  CAF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaurav Gupta, MD

CONTACT

6139451601; gaurav.gupta@forces.gc.ca

Sean Meredith, PharmD

CONTACT

6139451601; SEAN.MEREDITH@forces.gc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The order of administration for each scenario and injection type will be randomized to exclude any bias. To minimize risk to participants, active drug products and live/loaded autoinjectors will not be used. The target injection will be placed in an inanimate object (e.g. orange) or phantom simulator (i.e. inanimate object such as a gel or organic material such as jello or fruit to simulate an injection experience).
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 10, 2022
• Study Start: April 30, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)