Acute Pain Due to TraumaNCT06351137
Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain
A study testing Intravenous administration and Intranasal administration in people with Acute Pain Due to Trauma and Analgesia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Pain Due to Trauma, Analgesia
- What is being tested?
- Intravenous administration and Intranasal administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Mar 2024to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All navy healthcare personnel attending (simulation) training on prehospital trauma care.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Intravenous administration, Intranasal administration
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administrationOther
Analgesia is administered intravenously.
Intranasal administrationOther
Analgesia is administered intranasally using an atomizer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intravenous administration; Other: Intranasal administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During simulation training (expected <5 minutes)
Secondary outcomes (4)
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.
Measured: During simulation training (expected <10 minutes)
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).
Measured: During simulation training (expected <5 minutes)
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.
Measured: During simulation training (expected <0.5 minute)
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"
Measured: Directly after completion of simulation training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start13 Mar 2024
- Primary completion10 Sep 2024
- Study completion10 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Pain Due to TraumaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Weenink, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Markus W Hollmann, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351137
- Sponsor's protocol ID
- INIV2023
- Status last verified
- Jan 2025
- First submitted
- 8 Mar 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timecost of Intranasal Versus Intravenous Analgesia in Traumatic Pain
- ClinicalTrials.gov ID
- NCT06351137
- Acronym / sponsor ID
- INIV2023
- Conditions
- Acute Pain Due to Trauma, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 10 Sep 2024 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV first | Other | Other: Intravenous administration, Other: Intranasal administrationSubjects in this group will be instructed to use intravenous administration in the first scenario and use intranasal administration in the second scenario. |
| IN first | Other | Other: Intravenous administration, Other: Intranasal administrationSubjects in this group will be instructed to use intranasal administration in the first scenario and use intravenous administration in the second scenario. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All navy healthcare personnel attending (simulation) training on prehospital trauma care.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous administrationAnalgesia is administered intravenously. | Other | IN first, IV first |
| Intranasal administrationAnalgesia is administered intranasally using an atomizer. | Other | IN first, IV first |
Primary outcome
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.
4 secondary outcomes
Total time spent on scene (minutes)
Time frame: During simulation training (expected <10 minutes)
Time required for obtaining IV access
Time frame: During simulation training (expected <5 minutes)
Time required preparing IN administration
Time frame: During simulation training (expected <0.5 minute)
Satisfaction of the navy nurse regarding the used route of administration.
Time frame: Directly after completion of simulation training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus W Hollmann, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous administration and Intranasal administration in people with Acute Pain Due to Trauma and Analgesia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time required for administration of analgesic (minutes) (time frame: During simulation training (expected <5 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.