Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain

NCT ID: NCT06351137

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-13

Study Completion Date

2024-09-10

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Pain Due to Trauma Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Intravenous administration

Intervention Type OTHER

Analgesia is administered intravenously.

Intranasal administration

Intervention Type OTHER

Analgesia is administered intranasally using an atomizer.

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.

Group Type OTHER

Intravenous administration

Intervention Type OTHER

Analgesia is administered intravenously.

Intranasal administration

Intervention Type OTHER

Analgesia is administered intranasally using an atomizer.

Interventions

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Intravenous administration

Analgesia is administered intravenously.

Intervention Type OTHER

Intranasal administration

Analgesia is administered intranasally using an atomizer.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All navy healthcare personnel attending (simulation) training on prehospital trauma care.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Robert Weenink

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus W Hollmann, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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Amsterdam UMC

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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INIV2023

Identifier Type: -

Identifier Source: org_study_id

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