Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

Prehospital treatment of acute traumatic pain is common in military practice. Analgesics are usually administered intravenously (IV). Research from the civil prehospital environment shows that obtaining IV access can be difficult and time consuming, delaying onset of treatment. The challenges for obtaining IV access in the military prehospital setting are even bigger, for example in combat environments. However, this has not been assessed.

Current guidelines also offer alternative routes of administration for analgesics, for example intranasal (IN) administration. IN administration is a fast, easy and effective route of administration. This study determines whether IN administration of analgesia is faster and leads to increased healthcare provider satisfaction compared to IV administration in patients with acute traumatic pain in a simulated military prehospital environment.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Acute Pain Due to Trauma
• Intervention / Treatment: Other: Intravenous administration; Other: Intranasal administration

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert P Weenink, PhD; Phone Number: +31205669111; Email: r.p.weenink@amsterdamumc.nl
• Study Contact Backup: Name: Midas N de Grunt, MD; Phone Number: +31205669111; Email: m.n.degrunt@amsterdamumc.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1105AZ
      • Recruiting
      • Amsterdam UMC
      • Contact: Midas N de Grunt, MD; Phone Number: +31205669111; Email: m.n.degrunt@amsterdamumc.nl
      • Principal Investigator: Markus W Hollmann, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All navy nurses attending (simulation) training on prehospital trauma care.

Exclusion Criteria: none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: IV first; Subjects in this group will be instructed to use intravenous administration in the first scenario and use intranasal administration in the second scenario.	Other: Intravenous administration; Analgesia is administered intravenously.; Other: Intranasal administration; Analgesia is administered intranasally using an atomizer.
Other: IN first; Subjects in this group will be instructed to use intranasal administration in the first scenario and use intravenous administration in the second scenario.	Other: Intravenous administration; Analgesia is administered intravenously.; Other: Intranasal administration; Analgesia is administered intranasally using an atomizer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for administration of analgesic (minutes)	Time interval starts when healthcare provider grabs the first required item (e.g. tourniquet, nasal atomizer, ampoule) from the medicine bag. Time interval ends upon completed administration of analgesic.	During simulation training (expected <5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time spent on scene (minutes)	Time interval starts when healthcare provider arrives at the patient. Time interval ends when analgesia has been administered and used materials have been disposed.	During simulation training (expected <10 minutes)
Time required for obtaining IV access	Time interval starts when healthcare provider grabs the first required item (e.g. tourniquet or alcohol wipe) from the medicine bag. Time interval ends when the IV catheter has been taped or flushed (whichever comes last).	During simulation training (expected <5 minutes)
Time required preparing IN administration	Time interval starts when healthcare provider grabs the nasal atomizer. Time interval ends when the nasal atomizer has been placed on the syringe.	During simulation training (expected <0.5 minute)
Satisfaction of the navy nurse regarding the used route of administration.	This is rated on a 0-10 Likert scale, where 0 represents "extremely unsatisfactory" and 10 represents "extremily satisfactory"	Directly after completion of simulation training

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Markus W Hollmann, PhD, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: INIV2023

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