Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

NCT06351137 | Completed

• 1 other identifier: INIV2023
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pain Due to Trauma; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total time spent on scene (minutes)

  During simulation training (expected <10 minutes)

• Time required for obtaining IV access

  During simulation training (expected <5 minutes)

• Time required preparing IN administration

  During simulation training (expected <0.5 minute)

• Satisfaction of the navy nurse regarding the used route of administration.

  Directly after completion of simulation training

Study Arms (2)

IV first

OTHER

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; Other: Intranasal administration

IN first

OTHER

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; Other: Intranasal administration

Interventions

Intravenous administration OTHER

Analgesia is administered intravenously.

IN first; IV first

Intranasal administration OTHER

Analgesia is administered intranasally using an atomizer.

IN first; IV first

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Agnosia

Interventions

Administration, Intravenous; Administration, Intranasal

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Administration, Mucosal; Administration, Topical

Study Officials

• Markus W Hollmann, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: April 8, 2024
• Study Start: March 13, 2024
• Primary Completion: September 10, 2024
• Study Completion: September 10, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)