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OpenTrials
Completed

NCT Number: NCT06351137

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1105AZ, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

none

Treatment and study plan

Intravenous administration

Other

Analgesia is administered intravenously.

Intranasal administration

Other

Analgesia is administered intranasally using an atomizer.

Primary outcomes

  1. Time required for administration of analgesic (minutes)

    Time frame: During simulation training (expected <5 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.

Secondary outcomes

  1. Total time spent on scene (minutes)

    Time frame: During simulation training (expected <10 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.

  2. Time required for obtaining IV access

    Time frame: During simulation training (expected <5 minutes)

    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).

  3. Time required preparing IN administration

    Time frame: During simulation training (expected <0.5 minute)

    Time interval starts when healthcare provider grabs the nasal atomizer. Time interval ends when the nasal atomizer has been placed on the syringe.

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

    Time frame: Directly after completion of simulation training

    This is rated on a 0-10 Likert scale, where 0 represents "extremely unsatisfactory" and 10 represents "extremily satisfactory"

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 8, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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