Assessment of Injectable Medication Platforms

Quantitative Assessment of Injectable Medication Delivery Practices

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.

Study Overview

• Status: Recruiting
• Conditions: Bleeding; Allergic Reaction; Overdose Antidote
• Intervention / Treatment: Device: Autoinjector; Device: Standard Injector; Device: Prefilled

Detailed Description

Research Objective:

To understand the efficiency of injectable medication delivery in the Canadian Forces and civilian world for improved care delivery in military and pre-hospital environments.

Participants:

Approximately thirty (30) participants will be recruited for the study.

Methods:

Data will be obtained on the technical comparison of efficiency for pre-filled syringes to the current standards of administration. The timing and accuracy for administering saline to an inanimate object using the traditional methods versus a pre-filled medication syringes will be compared.

Risks and Risk Mitigation:

The participants in this study are all practicing military personnel who are able to give free and informed consent. To reduce undue influence, LCol Meredith and Dr Gupta will not be involved in recruitment. As a result, these participants are a low vulnerability group. The risk of any adverse events is low since data scenarios, and participants may choose to skip any questions or scenarios that participants do not wish to do. Investigators will remind all participants that their participation is voluntary, and that they may choose to withdraw or stop at any time.

Benefits and Military Significance:

The proposed study will be the first of its kind to assess the efficiency of various injectable medication delivery platforms. This data will provide a background for improving injectable drug delivery practices in various setting (eg military and pre-hospital settings), including the potential to inform novel medical device development.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean Meredith, PharmD; Phone Number: 6139451601; Email: SEAN.MEREDITH@forces.gc.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1K 0T2
      • Recruiting
      • Canadian Forces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Injection Scenario; 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; 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).; Device: Standard Injector; 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).; Device: Prefilled; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of injection failures and/or injuries associated with each trial	Any human errors or device failures will be recorded	immediately after intervention
Perceived difficulty of injection based on type of system	On a scale of 1-5 participants will rate difficult using autoinjector, prefilled and standard medication delivery systems. Going from 1-5 represents a decreasing degree of difficulty (hardest =5 and easiest = 1 with 3 being neutral)	immediately after intervention

Collaborators and Investigators

• Sponsor: Canadian Forces Health Services Centre Ottawa
• Investigators: Principal Investigator: Gaurav Gupta, MD, CAF

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2022
• Primary Completion (ANTICIPATED): December 1, 2024
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 5, 2022
• First Posted (ACTUAL): May 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: medication; needle; autoinjector; syringe
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2020-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No