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CompletedNCT06351137Updated Jan 29, 2025

Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

An interventional study of Intravenous administration and Intranasal administration in Acute Pain Due to Trauma and Analgesia, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Pain Due to Trauma
  • Analgesia

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03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 19 is below the median of 90 across 732 interventional studies indexed under Acute Pain.

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Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 512 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria: none

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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 · Other: Intranasal administration

  • 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 · Other: Intranasal administration

Interventions

  • OtherIntravenous administration

    Analgesia is administered intravenously.

  • OtherIntranasal administration

    Analgesia is administered intranasally using an atomizer.

06

What researchers measure

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.

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

Secondary outcomes

  1. 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.

    Time frame: During simulation training (expected <10 minutes)

  2. 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).

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

  3. 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.

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

  4. 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"

    Time frame: Directly after completion of simulation training

07

Study locations

1 site
  • Amsterdam UMC
    Amsterdam, Noord-Holland 1105AZ, Netherlands
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06351137
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Responsible party
Robert Weenink (Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Principal investigator
First posted
Apr 8, 2024
Start date
Mar 13, 2024
Primary completion
Sep 10, 2024
Completion
Sep 10, 2024
Last update
Jan 29, 2025

Study contacts

Markus W Hollmann, PhD
principal investigator · Amsterdam UMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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