Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

Analgesia Clinical Trial

Official title:

Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351137
• Other study ID #: INIV2023
• Status: Recruiting
• Phase: N/A
• Start date: March 13, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Robert P Weenink, PhD
• Phone: +31205669111
• Email: r.p.weenink[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All navy nurses attending (simulation) training on prehospital trauma care. Exclusion Criteria: none

Related Conditions & MeSH terms

• Acute Pain
• Acute Pain Due to Trauma
• Analgesia

Intervention

Other:
• Intravenous administration
Analgesia is administered intravenously.
• Intranasal administration
Analgesia is administered intranasally using an atomizer.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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